In 2018, Eduardo Hariton, MD, and Joseph Locascio, PhD, from Massachusetts General Hospital, published an article in the British Journal of Obstetrics and Gynaecology titled (1):
Randomised Controlled Trials—
The Gold Standard for Effectiveness Research
As stated in the title, the authors reaffirm that the gold standard for healthcare scientific research is the Randomized Controlled Trial (RCT).
In 2020, researchers from the Cleveland Clinic published a study in the journal Chest, the official journal of the American College of Chest Physicians, titled (2):
Randomized Controlled Trials
The authors state:
“Randomized controlled trials (RCTs) are considered the highest level of evidence to establish causal associations in clinical research.”
The primary global source of health information is the United States’ National Library of Medicine (NLM). The NLM webpage states (3):
“The National Library of Medicine is the world’s largest biomedical library and a leader in research in computational health informatics. NLM plays a pivotal role in translating biomedical research into practice. NLM’s research and information services support scientific discovery, health care, and public health.
NLM enables researchers, clinicians, and the public to use the vast wealth of biomedical data to improve health.”
The search engine for the U.S. NLM is PUBMED (4). As of August 1, 2023, PUBMED indexed approximately 30,000 different scientific journals and claims an excess of 35 million citations. However, the vast majority of published healthcare studies in the NLM are not RCTs.
Alternative approach healthcare research, such as clinical studies or epidemiological studies, are vulnerable to criticism because they are not RCTs. Yet, when non-RCT healthcare research is published with promising or informative outcomes, the authors often point out that a limitation of their study is that it is not a RCT. They further note that their study only points out associations, not causations, and that causation would require a RCT. The authors will often conclude that the results of their study warrant a large, robust RCT.
It is shocking, unbelievable, that the medical use of opioids in America for the treatment of pain began based upon the weakest of evidence. A recent (2023) quantification of the magnitude of our opioid crisis states (5):
“The opioid crisis has claimed more than a half-million deaths over the past two decades and is one of the leading causes of injury deaths in the United States.”
Opium is a compound made from the poppy plant.
Opiates are compounds that can be purified directly from opium without modification. This includes morphine, codeine, methadone, and heroin.
Opioids are a synthetic form of opium that are made in a chemical lab. Drug companies have created more than 500 different opioid molecules, including:
- OxyContin (oxycodone)
- Percocet (oxycodone)
- Vicodin (hydrocodone)
- Dilaudid (hydromorphone)
Both opiate and opioid drugs are known as “narcotics.” Narcotic means sleep-inducing or pain suppressing.
The Centers for Disease Control and Prevention of the United States Government notes (6):
The Drug Overdose Epidemic: Behind the Numbers
- More than 932,000 Americans have died since 1999 from a drug overdose.
- 75% of these deaths in 2020 involved narcotics (opiates/opioids).
- Overdose deaths involving opioids, including prescription opioids, heroin, and synthetic opioids (like fentanyl), have increased by more than eight times since 1999.
- Over 82% of these deaths involved synthetic opioids, primarily fentanyl.
Side effects of opiates/opioids include insomnia, constipation, jittery nerves, and nausea (7). They also cause life-threatening side effects such as shallow breathing and slowed heart rate, leading to loss of consciousness and death.
Opiates/opioids can cause addiction. They can make your brain and body believe the drug is necessary for survival. As you learn to tolerate the dose you’ve been prescribed, you may find that you need even more medication to relieve the pain. “More than 2 million Americans misuse opioids, according to the National Institute on Drug Abuse.”
The Department of Justice of the United States government notes (8):
- In 2021, 107,622 lives were lost in the United States due to a drug overdose. This is an average of nearly 295 people per day.
- Drug overdoses are the leading cause of death for Americans ages 18- 45; 66% of these overdose deaths were attributable to opioids, primarily by illicit fentanyl.
- Fentanyl “is the most dangerous drug threat facing our nation.”
In 2017, the United States’ problem with opiates/opioids was quantified in the journal Annals of Internal Medicine in a study titled (9):
Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults
This survey used 51,200 adult subjects. The authors found:
- 8 million (37.8%) U.S. civilian, non-institutionalized adults used prescription opioids.
- 5 million adults misused opiate drugs (12.5%).
- 9 million US adults officially have an opiate use disorder.
- “More than one third of U.S. civilian, non-institutionalized adults reported prescription opioid use in 2015, with substantial numbers reporting misuse and use disorders.”
The authors note that the numbers they present are undoubtedly under representative of the opioid problem because they did not include an assessment of groups that are likely to take and to abuse these drugs, including:
- They did not survey homeless persons who were not living in shelters.
- They did not survey active-duty military personnel.
- They did not survey anyone in jail or other institutions.
Opiates have been a part of the human experience for thousands of years (10). The epidemic of deaths from narcotics in America began in 1980 when the prestigious New England Journal of Medicine published a letter-to-the-editor by physicians Jane Porter and Hershel Jick, titled (11):
Addiction Rare in Patients Treated with Narcotics
This publication was certainly not a qualified clinical trial nor a robust RCT.
Six years later (1986), pain physicians Russel Portenoy and Kathleen Foley published a small study in the prestigious journal Pain, titled (12):
Chronic Use of Opioid Analgesics in Non-malignant Pain:
Report of 38 Cases
Armed with these two anemic publications in top tier medical journals, drug companies, with their enormous finances, marketing, influence on medical education and on government policy, began their propaganda. The opioid crisis was born. The Netflix movie “Painkiller” (released July 2023) exposes many of the villains of this opioid crisis.
As crazy as it sounds, the first RCT to evaluate opioids for chronic pain was not done until 2018, long after the magnitude and seriousness of the opioid crisis was recognized by all players. It was published in the Journal of the American Medical Association, titled (13):
Effect of Opioid vs Non-opioid Medications
on Pain-Related Function in Patients with Chronic Back Pain
or Hip or Knee Osteoarthritis Pain:
This study was a Randomized Clinical Trial (RCT) that involved 234 subjects. Chronic pain was defined as pain nearly every day for 6 months or more. The authors state:
“Rising rates of opioid overdose deaths have raised questions about prescribing opioids for chronic pain management.”
“Because of the risk for serious harm without sufficient evidence for benefits, current guidelines discourage opioid prescribing for chronic pain.”
“Studies have found that treatment with long-term opioid therapy is associated with poor pain outcomes, greater functional impairment, and lower return to work rates.”
“Treatment with opioids was not superior to treatment with non-opioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.”
The bottom line: in this first credible RCT evaluating the efficacy of opioids for the treatment of chronic pain, it showed that opioids had no clinical benefit over other much safer drugs. One might ask: how did opioids become the first drug of choice for the treatment of chronic pain, especially in the face of no RCTs to document their superiority over other options?
This study was reviewed by the Back Letter in an article titled (14):
Landmark Trial Punctures the Myth That Opioids
Provide Powerful Relief of Chronic Pain
What If the New Opioid Study Had Been Published In 1995? How Many Lives Would Have Been Saved?
It is difficult to avoid a sense of profound regret upon hearing the details of the new randomized controlled trial on long-term opioid use by Erin Krebs, MD, and colleagues.
Had this study been conducted and published in 1995, it might have saved 300,000 lives or more—lives lost to opioid overdoses.
Like many major treatment fads for low back pain, the movement to treat chronic noncancer pain with opioids had a flimsy evidence foundation.
Physicians adopted opioids in the early 1990s as a long-term treatment for chronic pain based on the most paltry of evidence—case series and other low-grade evidence.
Many observers blame a 1986 case series by Russell Portenoy, MD, and Kathleen Foley, MD, for jump-starting the use of long-term opioids for chronic, noncancer pain.
They reported 38 cases involving long-term opioid therapy for chonic nonmalignant pain and made the erroneous conclusion that opioids could be used safely and effectively in the long-term treatment of chronic pain.
Emergency physician Chris Johnson, MD, wrote a commentary at CNN.com, describing one such data source:
“As a physician in training, I remember being told that the risk of addiction for patients taking opioids for pain was ‘less than one percent.’ What I was not told was that there was no good science to suggest rates of addiction were really that low.”
Johnson pointed out that this statistic was not based on valid scientific data. It was based on a short letter-to-the editor in the New England Journal of Medicine by two Boston-area medical researchers in 1980.
Many other confounding influences came into play in the genesis of the opioid crisis: unrealistic support for long-term opioids from pain specialists and major pain societies, troubling conflicts of interest between pain specialists and opioid manufacturers, not skeptical attitudes from primary care physicians and their societies, felonious marketing by at least one opioid manufacturer, …and a lengthy series of other poor decisions by medical systems, regulators, researchers and healthcare providers.
Opioids are perceived as strong pain relievers, but our data showed no benefits of opioid therapy over non-opioid medication therapy for pain.
The data do not support opioids’ reputation as “powerful painkillers.”
This is an impressive study. It is the first clinical trial comparing opioid and non-opioid medications with long-term follow-up. It provides strong evidence that opioids should not be the first line of treatment for chronic musculoskeletal pain.
Opioids are not achieving the benefits for which they are marketed. And everyone is now well aware of the adverse effects of opioids.
The reader is reminded that this study by Krebs (13) looked at the use of opioids for chronic pain. Do opioids work for acute pain syndromes, specifically for acute low back and/or neck pain? This question was assessed in a top tier medical journal last month (July 2023), The Lancet, titled (15):
Opioid Analgesia for Acute Back Pain and Neck Pain (the OPAL Trial):
A Randomised Placebo-controlled Trial
This study is special. It is the first RCT looking at opioids for acute spinal pain, and it was placebo controlled. The study involved 151 participants in the opioid group and 159 in the placebo group. Adverse events linked to opioid use can be serious, including dependency, misuse, and overdose can lead to death. The authors note that studies sponsored by drug companies are often unreliable. They state:
“There are no systematic reviews of opioid analgesics versus placebo for acute spinal pain.”
“This study is not sponsored by [the drug] industry and is the first placebo-controlled trial of an opioid analgesic, without the addition of another pain medicine, for acute low back and neck pain.”
The authors make these relevant observations:
“Low back pain and neck pain are very prevalent, with low back pain being the largest contributor to years lived with disability globally, and neck pain being the fourth largest.”
“Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce.”
“The use of opioids for the management of acute low back pain and neck pain is not supported by direct and robust evidence.”
The authors found that being prescribed an opioid for acute spinal pain actually increased the patient’s pain at both the 26- and 52-week follow-up assessment. In other words, not only did the opioid not work, it actually worsened the patients pain in the long term.
The authors also found that even a short course of opioids can increase the risk of long-term misuse, and 35% of participants in the opioid group reported at least one adverse event. In contrast, RCTs on similar patients show that chiropractic care is associated with no adverse events (16). These authors concluded:
“This study found there was no benefit of an opioid compared with placebo in people receiving guideline care for acute non-specific low back pain or neck pain.”
“Our findings say that not only are opioids not going to benefit individuals with back and neck pain, but they might also cause worse outcomes even after short-term judicious use.”
“Our findings show that even judicious, short-term use of an opioid conferred no benefits in pain reduction and led to a small increase in pain at the medium-term and long-term compared with placebo.”
“There is no evidence that opioids should be prescribed for people with acute non-specific low back pain or neck pain.”
“Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo.”
These authors explain that clinical practice guidelines for physicians that advocate for the judicious use of opioids for acute spinal pain syndromes are erroneous and that they should be changed. They note that their study shows no benefit, risks of harms, risks of misuse, and increased risk of long-term pain. As such, they support a shift in the focus of practice guideline for spinal pain management from pharmacological to non-pharmacological treatments. These non-pharmacological treatments endorse spinal manipulation.
It is no longer controversial to understand that chiropractic and spinal manipulation are safe and effective treatments for spinal pain (17, 18, 19, 20, 21, 22, 23).
In 2018, a study was published in The Journal of Alternative and Complementary Medicine, titled (24):
Association Between Utilization of Chiropractic Services
for Treatment of Low-Back Pain and Use of Prescription Opioids
The authors analyzed the health insurance claims of 6,868 low back pain subjects from New Hampshire. The authors note:
“There is little evidence that opioids improve chronic pain, function, or quality of life.”
“Among U.S. adults prescribed opioids, 59% reported having back pain.”
“Among New Hampshire adults with office visits for non-cancer low-back pain, the adjusted likelihood of filling a prescription for an opioid analgesic was 55% lower for recipients of services provided by doctors of chiropractic compared with non-recipients.”
“Pain management services provided by doctors of chiropractic may allow patients to use lower or less frequent doses of opioids, leading to lower costs and reduced risk of adverse effects.”
“[Chiropractic care] could exert a positive impact on patients with low-back pain by reducing unnecessary care, lowering costs, and improving safety.”
“Pain relief resulting from services delivered by doctors of chiropractic may allow patients to use lower or less frequent doses of opioids, leading to reduced risk of adverse effects.”
Also, in 2018, the journal Pain Medicine published a study titled (25):
Opioid Use Among Veterans of Recent Wars
Receiving Veterans Affairs [VA] Chiropractic Care
The authors are from Yale School of Medicine, School of Medicine Boston University, and University of Massachusetts Medical School. The VA began providing chiropractic services on-site in 2004 and has expanded implementation each year thereafter. In the VA, chiropractic patients are seen overwhelmingly for low back and/or neck musculoskeletal pain conditions. In private sector populations, increases in chiropractic care is correlated with reduced opioid use. The authors note:
“Apart from the potential to reduce pain and improve function in patients with musculoskeletal conditions, chiropractic care may have an impact on opioid use in such patients.”
“Chiropractic care is more likely to be a replacement for, rather than an addition to, opioid therapy for chronic musculoskeletal pain conditions in the VA.”
“Our results, along with the previous literature, suggest that expanding access to chiropractic care should be a key policy consideration for the VA, congruent with national initiatives aimed to increase the use of evidence-based nonpharmacological treatments for chronic musculoskeletal pain.”
In 2019, a study was published in the journal BMJ Open titled (26):
Observational Retrospective Study of the Initial Healthcare Provider for New-onset Low Back Pain with Early and Long-term Opioid Use
The authors examined the association of initial conservative therapy provider treatment (chiropractors, acupuncturists, physical therapists) on opioid use in a national sample (216,504) of individuals with a new-onset low back pain (LBP). The most frequent initial conservative provider seen was a chiropractor. The authors note:
“Comparisons of the treatment patterns of primary care physicians and conservative therapists (defined as chiropractors, physical therapists, acupuncturists) suggest that the use of conservative therapies for LBP may decrease the likelihood of opioid use.”
“For early opioid use, patients initially visiting chiropractors had 90% decreased odds.”
“Initial visits to chiropractors or physical therapists is associated with substantially decreased early and long-term use of opioids.”
In 2020, a study was published in the journal Pain Medicine titled (27):
Association Between Chiropractic Use and
Opioid Receipt Among Patients with Spinal Pain
The authors are from Yale School of Medicine. This meta-analysis used 6 chiropractic studies, 5 that focused on back pain and 1 on neck pain. “All six studies (62,624 patients) provided sufficient data and were judged similar enough to be pooled for meta-analysis.” The authors note:
“Chiropractors predominantly manage spinal conditions, with back conditions being the most common reason to seek chiropractic care.”
“The main finding of the review was that all included studies demonstrated a negative association between use of chiropractic care and opioid prescription receipt.”
“Chiropractic users had 64% lower odds of receiving an opioid prescription than nonusers.”
Also in 2020, a study was published in the journal Pain Medicine, titled (28):
Impact of Chiropractic Care on Use of Prescription Opioids
in Patients with Spinal Pain
The objective of this study was to evaluate the impact of chiropractic utilization upon use of prescription opioids among 101,221 patients with spinal pain. The authors note:
“Among patients with spinal pain disorders, for recipients of chiropractic care, the risk of filling a prescription for an opioid analgesic over a six-year period was reduced by half, as compared with non-recipients.”
“[There is] accumulating evidence for increased utilization of chiropractic services as an upstream strategy for reducing dependence upon prescription opioid medications.”
In 2022, a study was published in the Journal of Chiropractic Medicine, titled (29):
Associations Between Early Chiropractic Care and Physical Therapy
on Subsequent Opioid Use Among Persons with Low Back Pain
This study assessed 40,929 patients with low back pain. The authors note:
“The use of chiropractic care within 30 days of LBP diagnosis was associated with diminished use of opioids in the short term and, in particular, the long term, in which the risk of long-term opioid use was almost cut in half.”
“Chiropractic care was associated with substantial reduction in likelihood of any opioid use and long-term opioid use [by 44%].”
Also, in 2022, a study was published in the journal Chiropractic & Manual Therapies, titled (30):
Association Between Chiropractic Care and Use of Prescription Opioids
Among Older Medicare Beneficiaries with Spinal Pain
This retrospective observational study examined 55,949 Medicare beneficiaries diagnosed with spinal pain, of whom 9,356 were recipients of chiropractic care and 46,593 were non-recipients. The authors note:
“The adjusted risk of filling an opioid prescription within 365 days of first office visit was 56% lower among [chiropractic] recipients as compared to nonrecipients.”
Among early recipients of chiropractic care, the reduction of filling an opioid prescription was 62% lower as compared to non-recipients.
“Our results suggest that—in addition to lower cost and more efficient utilization of clinical resources—early chiropractic care for spinal pain is also associated with improved patient safety as compared to conventional medical care, at least with regard to use of opioids.”
“Among older Medicare beneficiaries with spinal pain, use of chiropractic care is associated with significantly lower risk of filling an opioid prescription.”
These studies support that all patients with spine pain syndromes should try chiropractic care prior to using opiates/opioids pain drugs.
- Hariton WE, Locascio JJ; Randomised Controlled Trials—The Gold Standard for Effectiveness Research; British Journal of Obstretics and Gynacology (BJOG); December 2018; Vol. 125; No. 13; p. 1716.
- Zabor EC, Kaizer AM, Hobbs BP; Randomized Controlled Trials; Chest; July 2020; Vol. 158; No. 1S; pp. S79-S87.
- https://www.nlm.nih.gov/ (accessed August 1, 2023).
- https://pubmed.ncbi.nlm.nih.gov/ accessed August 1, 2023.
- Sun D, Graham A, Feldmeyer B, Cullen FT, Kulig TC; Public Opinion about America’s Opioid Crisis: Severity, Sources, and Solutions in Context; Deviant Behavior; 2023; Vol. 44; No. 4; 567-590.
- https://www.cdc.gov/opioids/data/index.html; accessed August 12, 2023.
- https://www.cdc.gov/opioids/basics/index.html; accessed August 12, 2023.
- https://www.justice.gov/opioidawareness/opioid-facts; accessed August 12, 2023.
- Han B, Wilson M. Compton WM, Blanco C, Crane E, Lee J, Jones CM; Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults: 2015 National Survey on Drug Use and Health; Annals of Internal Medicine; September 2017; Vol. 167; No. 5; pp. 293-301.
- Offit PA; Pandora’s Lab: Seven Stories of Science Gone Wrong; National Geographic; 2017.
- Porter J, Jick H; Addiction Rare in Patients Treated with Narcotics; New England Journal of Medicine; January 10, 1980; Vol. 302; No. 2; P. 123.
- Portenoy RK, Foley KM; Chronic Use of Opioid Analgesics in Non-malignant Pain: Report of 38 cases; Pain; May 1986; Vol. 25; No. 2; pp. 171-186.
- Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S; Effect of Opioid vs Non-opioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial; Journal of the American Medical Association; March 6, 2018; Vol. 319; No. 9; pp. 872-882.
- The BackLetter; Landmark Trial Punctures the Myth That Opioids Provide Powerful Relief of Chronic Pain; July 2017; Vol. 32; No. 7; pp. 73-81.
- Jones CMP, Day RO, Koes BW, Latimer J, Maher CG, McLachlan AJ, Billot L, Shan S, Lin CWC; Opioid Analgesia for Acute Back Pain and Neck Pain (the OPAL Trial): A Randomised Placebo-controlled Trial; Lancet; July 22, 2023; Vol. 402; epub.
- Giles LGS, Muller R; Chronic Spinal Pain: A Randomized Clinical Trial Comparing Medication, Acupuncture, and Spinal Manipulation; Spine; July 15, 2003; Vol. 28; No. 14; pp. 1490-1502.
- Kirkaldy-Willis WH, Cassidy JD; Spinal Manipulation in the Treatment of Low Back Pain; Canadian Family Physician; March 1985; Vol. 31; pp. 535-540.
- Meade TW, Dyer S, Browne W, Townsend J, Frank OA; Low back pain of mechanical origin: Randomized comparison of chiropractic and hospital outpatient treatment; British Medical Journal; Vol. 300; June 2, 1990; pp. 1431-1437.
- Giles LGF, Muller R; Chronic Spinal Pain: A Randomized Clinical Trial Comparing Medication, Acupuncture, and Spinal Manipulation; Spine, July 15, 2003; Vol. 28; No. 14; pp. 1490-1502.
- Muller R, Giles LGF; Long-Term Follow-up of a Randomized Clinical Trial Assessing the Efficacy of Medication, Acupuncture, and Spinal Manipulation for Chronic Mechanical Spinal Pain Syndromes; Journal of Manipulative and Physiological Therapeutics; January 2005; Vol. 28; No. 1; pp. 3-11.
- Kirkaldy-Willis WH; Managing Low Back Pain; Churchill Livingstone; 1983; p. 19.
- Cifuentes M, Willetts J, Wasiak R; Health Maintenance Care in Work-Related Low Back Pain and Its Association with Disability Recurrence; Journal of Occupational and Environmental Medicine; April 14, 2011; Vol. 53; No. 4; pp. 396-404.
- Senna MK, Machaly SA; Does Maintained Spinal Manipulation Therapy for Chronic Nonspecific Low Back Pain Result in Better Long-Term Outcome? Randomized Trial; SPINE; August 15, 2011; Vol. 36; No. 18; pp. 1427–1437.
- Whedon JM, Toler AWJ, Goehl JM, Kazal LA; Association Between Utilization of Chiropractic Services for Treatment of Low-Back Pain and Use of Prescription Opioids; The Journal of Alternative and Complementary Medicine; June 2018; Vol. 24; No. 4; pp. 552-556.
- Lisi AJ, Corcoran KL, DeRycke EC, Bastian LA, Becker WC and 11 more; Opioid Use Among Veterans of Recent Wars Receiving Veterans Affairs Chiropractic Care; Pain Medicine; September 1, 2018; Vol. 19; Supplemental; pp. S54–S60.
- Kazis LE, Ameli O, Rothendler J, Garrity B, Cabral H, McDonough C, Carey K, Stein M, Sanghavi D, Elton D, Fritz J, Saper R; Observational Retrospective Study of the Initial Healthcare Provider for New-onset Low Back Pain with Early and Long-term Opioid Use; BMJ Open; September 2019; Vol. 9; No. 9; e028633.
- Corcoran KL, Bastian LA, Gunderson CG, Steffens C, Brackett A, Lisi AJ; Association Between Chiropractic Use and Opioid Receipt Among Patients with Spinal Pain: A Systematic Review and Meta-analysis; Pain Medicine; February 1, 2020; Vol. 21; No. 2; pp. e139-e145.
- Whedon JM, Toler AWJ, Kazal LA, Bezdjian S, Goehl JM, Greenstein J; Impact of Chiropractic Care on Use of Prescription Opioids in Patients with Spinal Pain; Pain Medicine; December 25, 2020; Vol. 21; No. 12; pp. 3567-3573.
- Acharya M, Chopram D, Smith AM, Fritz JM, Martin BC; Associations Between Early Chiropractic Care and Physical Therapy on Subsequent Opioid Use Among Persons with Low Back Pain in Arkansas; Journal of Chiropractic Medicine; June 2022; Vol. 21; pp. 67-76.
- Whedon JM, Uptmor S, Toler AJW, Bezdjian S, MacKenzie TA, Kazal LA; Association Between Chiropractic Care and Use of Prescription Opioids Among Older Medicare Beneficiaries with Spinal Pain: A Retrospective Observational Study; Chiropractic & Manual Therapies; January 31, 2022; Vol. 30; No. 1.
“Authored by Dan Murphy, D.C.. Published by ChiroTrust® – This publication is not meant to offer treatment advice or protocols. Cited material is not necessarily the opinion of the author or publisher.”