Rising Overdoses Show CDC Guideline Not Working

By Pat Anson, PNN Editor

Rising suicides and drug overdose deaths led to another decline in U.S. left expectancy last year, according to two sobering reports released by the Centers for Disease Control and Prevention.

Americans born in 2017 are expected to live 78.6 years, about one month less than those born in 2016. Life expectancy has fallen or remained flat in the U.S. for three consecutive years. The UK is the only other country in the industrialized world where life expectancy is dropping.

“Tragically, this troubling trend is largely driven by deaths from drug overdose and suicide. Life expectancy gives us a snapshot of the Nation’s overall health and these sobering statistics are a wakeup call that we are losing too many Americans, too early and too often, to conditions that are preventable,” CDC director Robert Redfield, MD, said in a statement.

Redfield, who almost lost a son to a drug overdose, has been nearly invisible since becoming CDC director in March. He has previously called the opioid epidemic “the public health crisis of our time” and pledged to “bring this epidemic to its knees.”

So far, the CDC’s strategies, including its controversial 2016 opioid prescribing guideline, are not working. As PNN has reported, the guideline may even be contributing to the rising number of suicides and overdoses.

Over 70,200 people died of a drug overdose in 2017 – the highest number on record and nearly a 10 percent increase from 2016. Deaths involving illicit fentanyl and other synthetic, mostly black market opioids surged 45 percent, while deaths involving natural or semisynthetic opioids, mostly painkillers such as oxycodone and hydrocodone, remained flat.  The rate of heroin deaths also remained unchanged.

SOURCE: CDC

SOURCE: CDC

CDC researchers noted that their data is flawed. Drug overdose deaths often involve multiple drugs, and “a single death might be included in more than one drug category.” A death “involving” a specific drug also doesn’t mean that drug was the cause of death. It only means the drug was present at the time of death.  The competency of medical examiners and coroners who complete death certificates can also vary widely from state to state.

The CDC reported that over 47,000 people committed suicide last year, nearly 4 percent more than in 2016. Suicide is the 10th leading cause of death among all age groups – and the 2nd leading cause of death among adolescents and young adults aged 10 to 34.

Reports Ignored Role of Antidepressants, ADHD Drugs

The CDC reports did not explore the role of drugs used to treat depression, anxiety and attention deficit hyperactive disorder (ADHD) in either suicides or overdoses.

According to a recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA), Xanax, Valium, Adderall and other psychotherapeutic drugs were involved in more overdoses in 2016 than prescription opioids.

A report this week from the Research Abuse Diversion and Addiction Related Surveillance System (RADARS), which tracks illicit drug use nationwide, underscores that emerging trend. RADARS found that the abuse of ADHD stimulants now exceeds the abuse of prescription opioids by Americans aged 19 or younger. The rising trend in “intentional exposures” to stimulants – which includes suicide – began in 2010 and is accelerating.    

PEDIATRIC CASES OF UNINTENTIONAL EXPOSURE (SOURCE: RADARS)

PEDIATRIC CASES OF UNINTENTIONAL EXPOSURE (SOURCE: RADARS)

“There have been more pediatric exposures involving stimulants than pediatric exposures involving natural/semi-synthetic opioid analgesics in every quarter since 4th quarter 2014. The increase appears to be driven by exposures where the intent of the patient was suicide,” the RADARS report found. 

“Multiple factors may contribute to the observed increase in suspected suicide exposures. The increase may reflect overall increases in suicides in the United States. It may also be a result of increases in stimulant misuse.” 

In the 2nd quarter of 2018, there were 822 reported cases of intentional exposure to stimulants among young people, while there were 503 cases involving opioid analgesics.

CDC: 50 Million Americans Have Chronic Pain

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention and other federal agencies have faced a fair amount of criticism over the years for adopting insensitive policies and guidelines that are often harmful to the pain community. But there are growing signs the CDC and other agencies are starting to listen to or at least better understand pain patients.

Today the CDC released a new report estimating that 50 million Americans – just over 20 percent of the adult population – have chronic pain. About 20 million of them have “high-impact chronic pain” -- pain severe enough that it frequently limits life or work activities. The estimates are based on the 2016 National Health Interview Survey of over 33,000 adults.

“Pain is a component of many chronic conditions, and chronic pain is emerging as a health concern on its own, with negative consequences to individual persons, their families, and society as a whole,” reported James Dahlhamer, PhD, of the CDC's Division of Health Interview Statistics.

Dahlhamer and his colleagues found that women, unemployed older adults, adults living in poverty, rural residents and people without public health insurance are significantly more likely to have chronic pain, while the risk of pain is lower for people with a bachelor’s degree.

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“Socioeconomic status appears to be a common factor in many of the subgroup differences in high-impact chronic pain prevalence,” they found. “Education, poverty, and health insurance coverage have been determined to be associated with both general health status and the presence of specific health conditions as well as with patients’ success in navigating the health care system. Identifying populations at risk is necessary to inform efforts for developing and targeting quality pain services.”

Different Estimates

Last week the National Institutes of Health (NIH) released its own research on high impact chronic pain (HICP), estimating that 11 million American adults have it -- about half the CDC’s estimate.

Both the NIH and CDC are part of the Department of Health and Human Services (HHS). It was not immediately clear why the two estimates are so far apart – or why two government agencies in the same department were studying the same thing at the same time.  

It’s certainly not the first time researchers have disagreed on the number of people in pain. In 2011, the Institute of Medicine released a landmark report claiming at least 100 million Americans have chronic pain, an estimate that one critic said was a “ridiculous number.” Other estimates range from 39 to 70 million.

“The multidimensional nature of chronic pain is not reflected in commonly used operational definitions… resulting in inordinately high prevalence estimates that limit our ability to effectively address chronic pain on a national level,” said Mark Pitcher, PhD, a visiting fellow at the National Center for Complementary and Integrative Health (NCCIH).

Like their counterparts at the CDC, NIH researchers found that socioeconomic factors play a significant role in high impact chronic pain. HICP sufferers not only have more severe pain, they are more likely to have mental and cognitive health issues, as well as substantially higher healthcare costs. About 83 percent of people with HICP are unable to work and one-third have difficulty with simple activities such as bathing and getting dressed.

“By differentiating those with HICP, a condition that is associated with higher levels of anxiety, depression, fatigue, and cognitive difficulty, we hope to improve clinical research and practice,” said co-author M. Catherine Bushnell, PhD, scientific director at NCCIH.

The concept of HICP was first proposed by the National Pain Strategy to better identify patients with pain severe enough to interfere with work and life activities. It also helps distinguish HICP from other types of chronic pain that are less impactful and more easily treated.

“It is crucial that we fully understand how people’s lives are affected by chronic pain. It will help improve care for individuals living with chronic pain and strategically guide our research programs that aim to reduce the burden of pain at the population level,” said Linda Porter, PhD, director of the Office of Pain Policy at the National Institute of Neurological Disorders and Stroke. 

The Food and Drug Administration has also recently taken steps to better understand the chronic pain population. In July, the FDA held a day-long public hearing and heard from dozens of pain patients and advocates. Some fought back tears as they testified about the lack of access to opioid medication and the deteriorating quality of pain care in the U.S.

Former CDC Director Arrested for Sexual Misconduct

By Pat Anson, Editor

Dr. Thomas Frieden, the former director of the Centers for Disease Control of Prevention, has been arrested on sexual misconduct charges in New York City.

Frieden turned himself in to police in Brooklyn Friday morning after being charged with forcible touching, harassment and third degree sex abuse, all misdemeanors. The charges stem from a complaint filed in July by a 55-year old unnamed woman who alleges the 57-year old doctor grabbed her buttocks without permission in his apartment last October. 

According to STAT, Frieden later apologized to the woman -- a longtime family friend -- and "tried to manipulate her into staying silent by citing his position and potential to save lives around the world."

Fried was arraigned Friday afternoon and released without bail, after a judge ordered him not to contact his accuser and to surrender his passport. He's due back in court October 11.

Frieden did not enter a plea. A spokesperson released a statement saying the incident "does not reflect Dr. Frieden’s public or private behavior or his values over a lifetime of service to improve health around the world.”

Frieden led the CDC from 2009 to 2017 and championed the agency’s controversial opioid prescribing guideline -- calling it an "excellent starting point" to prevent opioid abuse.

Although voluntary and only intended for primary care physicians, the guideline has been widely adopted by insurers, states and healthcare providers – resulting in many chronic pain patients losing access to opioid medication.

“This crisis was caused, in large part, by decades of prescribing too many opioids for too many conditions where they provide minimal benefit," Frieden wrote in a commentary published by Fox News.  “There are safer drugs and treatment approaches that can control pain as well or better than opioids for the vast majority of patients."

DR. THOMAS FRIEDEN

DR. THOMAS FRIEDEN

Frieden currently heads Resolve to Save Lives, a program of Vital Strategies, a non-profit health organization that is trying to improve public health worldwide.

Vital Strategies released a statement saying Frieden informed the organization in April about the misconduct allegation. His accuser does not work for Vital Strategies, but the organization hired an investigator to interview employees about Frieden. No inappropriate workplace behavior or harassment was found, according to Vital Strategies CEO Jose Castro.  

“I have known and worked closely with Dr. Frieden for nearly 30 years and have seen first-hand that he has the highest ethical standards both personally and professionally. Vital Strategies greatly values the work Dr. Frieden does to advance public health and he has my full confidence,” said Castro.

Frieden has an extensive background in epidemiology and infectious diseases, and his tenure at the CDC was marked by major efforts to combat the Ebola virus, fungal meningitis, influenza and the Zika virus.

Before his appointment as CDC director, Frieden was New York City’s health commissioner, where he led efforts to ban public smoking and remove unhealthy trans fats from restaurants. Frieden is married and has two children.

CDC Report Ignores Suicides of Pain Patients

By Pat Anson, Editor

The suicide rate in the United States continues to climb, with nearly 45,000 people taking their own lives in 2016, according to a new Vital Signs report by the Centers for Disease Control and Prevention.

The suicide rate in the U.S. is so high it rivals the so-called “opioid epidemic.” The number of Americans who died by suicide (44,965) exceeds the overdose deaths linked to both illicit and prescription opioids (42,249).  The nationwide suicide rate has risen by over 30 percent since 1999.

“Unfortunately, our data shows that the problem is getting worse,” said CDC Deputy Director Anne Schuchat, MD. “These findings are disturbing. Suicide is a public health problem that can be prevented.”  

Contrary to popular belief, depression is not always a major factor in suicides. The report found that less than half of the Americans who died by suicide had a diagnosed mental health issue. Substance abuse, physical health problems, and financial, legal or relationship issues were often contributing factors. So was the availability of firearms, which were involved in nearly half of all suicides.

But while CDC researchers can go into great detail about the methods, causes, demographics, ethnicity and even the drugs used by suicide victims, they did not investigate anecdotal reports of a growing number of suicides among pain patients.

“Our report found that physical health problems were present in about a fifth of individuals as circumstances considered to lead up to suicide," Schuchat said in a conference call with reporters. "That doesn’t differentiate whether it was intractable pain versus other conditions that might have been factors.”

CDC_site_pic.jpg

Asked directly if lack of access to opioid medication may be contributing to pain patient suicides, Schuchat said that federal agencies were “working on comprehensive pain management strategies,” but they were not investigating patient suicides, such as the recent tragic death of a Montana woman.

“We don’t have other studies right now. But I would say that the management of pain is a very important issue for the CDC and Health and Human Services,” she said.

PNN asked a CDC spokesperson if the agency was conducting any studies or surveys to determine whether the CDC's 2016 opioid guideline was contributing to patient suicides, and what impact it was having on the quality of pain care. The boilerplate response we received essentially said no, and that the CDC was only tracking prescriptions. 

"Through its quality improvement collaborative and its work with academic partners, CDC is evaluating the impact of clinical decisions on patient health outcomes by examining data on overall opioid prescribing rates, as well as measures such as dose and days’ supply, since research shows that taking opioids for longer periods of time or in higher doses increases a person’s risk of addiction and overdose," Courtney Leland said in an email.

As PNN has reported, the CDC’s guideline may be contributing to a rising number of suicides in the pain community.  In a survey of over 3,100 pain patients on the one-year anniversary of the guideline, over 40 percent said they had considered suicide because their pain was poorly treated.

Most patients said they had been taken off opioids or had their doses reduced to comply with the  CDC guideline, which has been widely adopted throughout the U.S. healthcare system. Many patients say they can’t even find a doctor willing to treat them.

‘Making Plans to End This Life’

“I am scared to death as pain for me is unbearable. If I cannot get a prescription for relief I will probably be one of those (suicide) statistics because as far as I'm concerned, my quality life would be gone and no longer worth living. I will be sure to leave a note telling the CDC to go to hell too,” one PNN reader said.

“If my life is reduced to screams of agony in my bed while my father has to watch, if that happens and I can’t take anymore suffering, I will leave a note (probably a very long one), and in it I will say that the people who are making these guidelines into law, should be charged with my homicide,” another patient wrote.

“My suicidal ideation has increased exponentially. I have now resorted to cutting and punishing myself in order to distract from the physical chronic pain I suffer with,” said another patient. “I am struggling terribly and can’t even get sleep. I have been making plans to end this life and if the pain continues without treatment, it will not be hard to do.”

“My wife has been talking about suicide as the only option to escape her chronic pain and migraine headaches. I am starting to think the same thoughts,” wrote a man who also suffers from chronic pain. “Many chronic pain patients left without a doctor or opiate painkillers will commit suicide to escape the pain and suffering. My wife and I included.”

British Columbia Revising Its Guideline

The Canadian province of British Columbia was one of the first to adopt the CDC guideline as a standard of practice for physicians. In April 2016, British Columbia declared a public health emergency because overdose deaths from illicit fentanyl, heroin and prescription drugs were soaring. In response, the College of Physicians and Surgeons of British Columbia released new professional standards and guidelines that were closely modeled after the CDC’s.

Two years later, the British Columbia guidelines are now being revised because too many patients were being denied care or abandoned by doctors fearful of prescribing opioids.

“Physicians cannot exclude or dismiss patients from their practice because they have used or are currently using opioids. It’s really a violation of the human rights code and it’s certainly discrimination and that’s not acceptable or ethical practice,” college registrar Heidi Oetter told The Globe and Mail.

Under the old guidelines, British Columbia doctors were strongly encouraged to keep opioid doses below 90 milligrams of morphine a day – the same recommendation as the CDC’s. Now they’re being told to use their own discretion and to work with patients in finding an effective dose.

“Hopefully it’s clear to physicians that the college is really expecting that they exercise good professional discretion, that they are really engaging patients in informed consent discussions and that patients are really aware of the potential risks that are associated with opioids, particularly if they’re taking them in conjunction with alcohol or sedatives,” Oetter said.

Not only were the old guidelines harmful to patients, they were ineffective in reducing overdoses. British Columbia still has the highest number of overdoses in Canada, with 1,448 deaths last year.

Overdoses also continue to soar in the United States – mostly due to illicit fentanyl and other street drugs. Will the CDC change its guideline -- as promised -- because it is harming patients and failing to reduce overdoses?

"CDC will revisit this guideline as new evidence becomes available," the agency said in 2016. "CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Today’s report on suicides indicates the agency has no plans to do either.

CDC Blames Fentanyl for Spike in Overdose Deaths

By Pat Anson, Editor

The Centers for Disease Control and Prevention released a new report today estimating that 63,632 Americans died of a drug overdose in 2016 – a 21.5% increase over the 2015 total.  

The sharp rise in drug deaths is blamed largely on illicit fentanyl, a powerful synthetic opioid that has become a scourge on the black market. Deaths involving synthetic opioids doubled in 2016, accounting for about a third of all drug overdoses and nearly half of all opioid-related deaths.

For their latest report, CDC researchers used a new “conservative definition” to count opioid deaths – one that more accurately reflects the number of deaths involving prescription opioids by excluding those attributed to fentanyl and other synthetic opioids. Over 17,000 deaths were attributed to prescription opioids in 2016, about half the number that would have been counted under the “traditional definition” used in previous reports.

CDC researchers recently acknowledged that the old method "significantly inflate estimates" of prescription opioid deaths.

The new report, based on surveillance data from 31 states and the District of Columbia, shows overdose deaths increasing for both men and women and across all races and demographics.  A wider variety of drugs are also implicated:

  • Fentanyl and synthetic opioid deaths rose 100%
  • Cocaine deaths rose 52.4%
  • Psychostimulant deaths rose 33.3%
  • Heroin deaths rose 19.5%
  • Prescription opioid deaths rose 10.6%

The CDC also acknowledged that illicit fentanyl is often mixed into counterfeit opioid and benzodiazepine pills, heroin and cocaine, likely contributing to overdoses attributed to those substances.

2016 DRUG RELATED DEATHS

West Virginia led the nation with the highest opioid overdose rate (43.4 deaths for every 100,000 residents), followed by New Hampshire, Ohio, Washington DC, Maryland and Massachusetts.  Texas has the lowest opioid overdose rate.

‘Inaccurate and Misleading” Overdose Data

The CDC's new method of classifying opioid deaths still needs improvement, according to John Lilly, DO, a family physician in Missouri who took a hard look at the government’s overdose numbers. Lilly estimates that 16,809 Americans died from an overdose of prescription opioids in 2016.

“Not all opioids are identical in abuse potential and likely lethality, yet government statistics group causes of death in a way that obscures the importance of identifying specific agents involved in deadly overdoses,” Lilly wrote in a peer reviewed article recently published in the Journal of American Physicians and Surgeons..

Lilly faults the National Institute on Drug Abuse (NIDA) -- which relies on a CDC database -- for using “inaccurate and misleading” death certificate codes to classify drug deaths. In its report for 2016, NIDA counted illicit fentanyl overdoses as deaths involving prescription opioids. As a result, deaths attributed to pain medication rose by 43 percent, at a time when the number of opioid prescriptions actually declined.

“That large an increase in one year from legal prescriptions does not make sense, particularly as these were being strongly discouraged,” Lilly wrote. “Rather than legal prescription drugs, illicit fentanyl is rapidly increasing and becoming the opioid of choice for those who misuse opioids... Targeting legal prescriptions is thus unlikely to reduce overdose deaths, but it may increase them by driving more users to illegal sources.”

Some researchers believe the government undercounts the number of opioid related deaths by as much as 35 percent because the actual cause of death isn’t listed on many death certificates.

“We have a real crisis, and one of the things we need to invest in, if we’re going to make progress, is getting better information,” said Christopher Ruhm, PhD, a professor at the University of Virginia and the author of a overdose study recently published in the journal Addiction.

Ruhm told Kaiser Health News the real number of opioid related deaths is probably closer to 50,000.

Kratom Linked to Salmonella Outbreak

By Pat Anson, Editor

Kratom just can’t get a break. In recent weeks, the herbal supplement used by millions of Americans to treat chronic pain, depression and addiction has been blamed by federal agencies for dozens of fatal overdoses and even been called an opioid.

Now the Centers for Disease Control and Prevention has linked kratom to a salmonella outbreak and is recommending that people "not consume kratom in any form."

The bacterial infection has sickened 28 people, eleven serious enough to be hospitalized, but there have been no deaths. The outbreak began in October 2017 and has reached 20 states scattered around the country, which are highlighted in the map below.

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“Epidemiologic evidence indicates that kratom is a likely source of this multistate outbreak,” the CDC said in a statement.

“In interviews, ill people answered questions about the foods they ate and other exposures in the months before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom have been identified at this time."

The CDC statement did not say that Salmonella bacteria had actually been found in any samples of kratom. Nor did it explain how kratom use in 8 out of 28 cases establishes a link or proves that it was "a likely source."

The only "epidemiologic evidence" that investigators have established is that when they compared bacteria samples from people who were infected, they found the bacteria were closely related genetically.

"This means that people in this outbreak are more likely to share a common source of infection," the CDC said. "At this time, CDC recommends that people not consume kratom in any form. The investigation indicates that kratom products could be contaminated with Salmonella and could make people sick."

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

In the current outbreak, the CDC says there could be more cases than the 28 reported, because salmonella infections typically take 2 to 4 weeks before the illnesses are confirmed.

salmonella bacteria

salmonella bacteria

It was a July 2016 report from the CDC that claimed kratom was linked to several overdose deaths and was “an emerging public health threat” that led the Drug Enforcement Administration to attempt to schedule kratom as an illegal controlled substance. Kratom supporters said the CDC research was amateurish and flawed, and a public outcry and lobbying campaign eventually forced the DEA to suspend its scheduling decision.

Earlier this month, the Food and Drug Administration released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.” The computer analysis and a recent FDA public health advisory may indicate the federal government is planning another attempt at scheduling.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties.

CDC: Opioid Prescribing Peaked in 2010

By Pat Anson, Editor

The Centers for Disease Control and Prevention admitted something today that most doctors and pain patients could have told the agency several years ago: prescriptions for opioid painkillers are declining.

In its newest Vital Signs report, the CDC analyzed prescription drug data compiled by QuintilesIMS from 2006 to 2015, and found that opioid prescribing in the U.S. peaked in 2010.  More recent data indicates the downward trend continued in 2016.

The CDC's new report undermines one of the main reasons behind the agency’s 2016 opioid prescribing guidelines, which falsely claimed that “opioid prescriptions per capita increased from 2007 to 2012,” when, in fact, they actually declined (see chart below).  

“Overall, opioid prescribing in the United States is down 18 percent since 2010,” said CDC Acting Director Anne Schuchat, MD.  

But even with that downward trend in prescribing, the CDC maintains opioid doses are still too high and contributing to the nation’s overdose crisis.

“Despite these overall declines, the bottom line remains we still have too many people getting opioid prescriptions for too many days at too high a dose,” said Schuchat. “In addition, the dramatic increase we’ve been seeing in heroin overdose is another tragic consequence of exposing too many people to prescription opioids, since most people who use heroin started off with misusing prescription opioids.”

Schuchat did not explain how her theory could account for the fact that heroin overdoses were increasing at a time when opioid prescriptions were declining. The association between heroin use and prescription painkillers is a common misconception at best, and a misleading half-truth at worst.

While many heroin users start out with painkillers (as well as tobacco, marijuana, alcohol and other drugs), most obtain their opioids illegally through friends, relatives and the black market. Heroin use by patients who are legally prescribed painkillers is actually quite rare, although the CDC's acting director makes it sound like one of the leading causes of overdoses.

"We're now experiencing the highest overdose drug death rates ever recorded in the United States, driven by prescription opioids and illicit opioids like heroin and illicitly manufactured fentanyl," Schuchat said.

Contrary to its own prescribing guideline, the CDC found that the average per capita daily morphine equivalent dose (MME) has been in decline for nearly a decade, from 59.7 MME per capita in 2006 to 48.1 MME in 2015.

The latter dose is well below the highest recommended limit of 90 MME in the CDC guidelines.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVELANT DOSE (MME)

Source: CDC/QuintilesIMS

The CDC also found a wide variation in prescribing practices around the country, with six times more opioids per resident dispensed in the highest-prescribing counties than in the lowest-prescribing ones.

Many of the high-prescribing counties are in rural, economically depressed areas such as Appalachia, where there are high rates of disability, suicide and unemployment; suggesting that the so-called "opioid epidemic" is actually more of an epidemic of despair. Other factors associated with high rates of opioid prescribing are a high percentage of white residents, high rates of uninsured or Medicaid recipients, and high rates of patients with diabetes and arthritis.