How Misuse of a Single Paragraph Ended Up Killing 60,000 Americans Per Year

By Dr. Mercola

Opioid addiction is at an all-time high in the U.S., and according to many addiction specialists, pain and hopelessness are primary drivers of this burgeoning crisis.¹ Limiting the availability of opioids and making overdose-reversal drugs and treatment for drug addiction more readily available are part of the answer. But it’s not enough.

We have to take a much deeper look at the root of the problem. What is causing all this physical pain and emotional distress in the first place? Clearly, the U.S. health care system is grossly ineffective when it comes to addressing chronic health problems. Whether pain is promoting hopelessness or the other way around is difficult to ascertain, but the two appear to be closely intertwined and need to be addressed together.

Somehow or another, we need to refocus our efforts to create lives worth living, and improve access to and information about basic disease prevention, which begins with diet and basic lifestyle choices — the kind of information I’ve focused on with my newsletter and website.

That said, it’s worth looking at how use of prescription opioids ended up getting so out of control. Doing so will reveal an oft-ignored truth: Drug companies may, and often do, promote drugs that do more harm than good. After all, drugs are profit centers, and drug companies are first and foremost beholden to their shareholders — not patients — who expect to make a decent profit from their investments.

To maximize sales, drug companies may hide information, misinform and/or outright lie about their medicines, and this is precisely what happened with narcotic painkillers.

The Paragraph That Spawned the Opioid Crisis

In 1980, a five-sentence-long letter to the editor was published in the New England Journal of Medicine (NEJM), one of the most prestigious medical journals in the world. Under the headline “Addiction Rare in Patients Treated With Narcotics,” the short letter, written by Jane Porter, a graduate student at Boston University Medical Center, read:

“Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction.

The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”

This turned out to be a letter with dire repercussions for millions of people in the decades to come. As noted in The Atlantic, this letter to the editor ended up being “so routinely mis-cited” it took on “a life of its own.”²

“[NEJM] … is issuing a corrective. It’s a new study³ … from a team led by David Juurlink at the University of Toronto that tracked how the five-sentence letter passed through the game of academic citation … to become evidence that opioids are safe for chronic pain. In fact, it said no such thing,” The Atlantic notes.

“… Hershel Jick, a doctor at Boston University Medical Center, had a database of hospital records that he used to monitor side effects from drugs … Something, perhaps a newspaper article, got Jick interested in looking at addiction. So he asked a graduate student, Jane Porter, to help calculate how many patients in the database got addicted after being treated with pain medicines, and dashed off a letter to the [NEJM].

Its brevity was commensurate with the effort involved … But as it began to accrue citations, its findings also began to mutate. Porter and Jick had only looked at hospitalized patients in regimented settings, but that detail got lost in the push to prescribe opioids to patients at home — an entirely different scenario.”

Drug Companies Latched on to Evidence That Wasn’t

In the years to come, this letter to the editor (most letters do not undergo any kind of peer-review) became an oft-cited piece of evidence used by drug companies and pain specialists alike. In all, it’s been cited more than 600 times since its publication, serving as the basis of misleading and inaccurate statements such as: “[P]ain population with no abuse history is literally at no risk for addiction,” and “There have been studies suggesting that addiction rarely evolves in the setting of painful conditions.”⁴

A remarkable 80 percent of the articles citing Jick’s letter failed to include the facts that his data pertained specifically to hospitalized patients receiving the drugs on a short-term basis. You simply cannot assume that because a narcotic is safe to use in the short term under careful monitoring by hospital staff, it will be safe long-term, and without careful monitoring.

According to Juurlink, “It’s difficult to overstate the role of this letter. It was the key bit of literature that helped the opiate manufacturers convince front-line doctors that addiction is not a concern.”⁵

Purdue Pharma used it as the basis for its claim that opioid addiction affects less than 1 percent of patients treated with the drugs. In a recent interview with The Associated Press (AP),⁶ Jick said he was “mortified that that letter to the editor was used as an excuse to do what these drug companies did.” He also clarified that his letter “only referred to people getting opioids in the hospital for a short period of time and has no bearing on long-term outpatient use.”

Researchers and journalists were no better. While the findings detailed in the letter were exceptionally narrow and the “study” less than thorough, researchers and journalists started referring to it as “extensive,” citing it as a “landmark report.” In 2001, Time magazine reported:⁷

“Many physicians now concede that patients have been undermedicated for decades, suffering needlessly. One reason was concern that big doses of opiates could depress respiration, but a large part stemmed from an exaggerated fear that patients would become addicted.

This fear, which continues to hold sway over American medicine, is basically unwarranted. A landmark study … found that only four became addicted to the [narcotic] drugs they received as patients. ‘You don’t see cancer patients running around robbing shopping malls to support their habits,’ notes Carr.”

NEJM Issues First-Ever Warning on 40-Year-Old Editor’s Note

Following the publication of Juurlink’s investigation into the citation trail leading from Jick’s letter to all manner of false claims, NEJM has now added an editor’s note to the 1980 letter,⁸ saying, “For reasons of public health, readers should be aware that this letter has been ‘heavily and uncritically cited’ as evidence that addiction is rare with opioid therapy.”

NEJM editor, Dr. Jeffrey Drazen, explained his note to AP, saying, “People have used the letter to suggest that you’re not going to get addicted to opioids if you get them in a hospital setting. We know that not to be true.”⁹ The journal has also added a link from Jick’s letter to Juurlink’s new study — a move that should eliminate most misuse in the future. As noted by Juurlink:¹⁰

“In conclusion, we found that a five-sentence letter … was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy. We believe that this citation pattern contributed to the North American opioid crisis by helping to shape a narrative that allayed prescribers’ concerns about the risk of addiction associated with long-term opioid therapy.

In 2007, the manufacturer of OxyContin and three senior executives pleaded guilty to federal criminal charges that they misled regulators, doctors and patients about the risk of addiction associated with the drug. Our findings highlight the potential consequences of inaccurate citation and underscore the need for diligence when citing previously published studies.”

60,000 Americans Overdosed in 2016

Opioid addiction and accidental overdoses are now taking a tremendous toll. According to U.S. Deputy Attorney General Rod Rosenstein, drug overdoses are now the leading cause of death among Americans under the age of 50!¹¹ In 2015, more than 52,000 Americans died from some form of drug overdose; 33,000 of them involved some form of opioid.

Preliminary data for 2016 reveals that death toll is anywhere from 59,000 to 65,000.¹² That’s a 19 percent increase in one year, and the largest annual increase of drug overdose deaths in U.S. history. Between 2014 and 2015, drug overdose deaths rose by 11 percent.¹³ The most common drugs involved in prescription opioid overdose deaths include¹⁴ methadone, oxycodone (such as OxyContin®) and hydrocodone (such as Vicodin®).

Synthetic opioids like fentanyl are also being abused by a rising number of people. A recent article in The New York Times¹⁵ highlights the tragedy of Grant Seaver and Ryan Ainsworth, two 13-year-olds who died after taking the synthetic opioid U-47700, also known as “pinky.” They got the drug from a teenage friend who had bought it on the dark web using bitcoin.

The sheer potency of synthetic opioids make them ideal for mailing. A standard envelope can hold enough fentanyl to get 50,000 people high. And, while the dark web marketplace Silk Road was shut down in 2013, others have popped up in its place, allowing people who might otherwise not have access to narcotics get them through the mail.

Disturbingly, rising fentanyl addiction also poses novel risks to first responders, law enforcement and even drug-sniffing dogs. The drug is so potent (anywhere from 500 to 1,000 percent more potent than morphine) that inhaling just a few flakes can be lethal.

In Ohio, a police officer nearly died from exposure to a fentanyl-related compound. During a routine traffic stop, he noticed a bag of white powder in the car. He used gloves and a mask for protection at the scene, but didn’t notice he’d gotten some on his shirt. Later, when a colleague pointed out the powder on his uniform, he brushed it off with his bare hand.

An hour later, he collapsed and had to be treated with FOUR doses of naloxone. He was lucky and survived the ordeal. Many fentanyl users are not. Deadly overdoses involving fentanyl rose by 50 percent between 2013 and 2014, and another 72 percent between 2014 and 2015.

Other Opioid Facts and Statistics

To truly understand the enormity of America’s drug problem, consider the following:

Drug Industry Responsible for Mass Addiction Now Tries to Cash in on It

Many believe the drug companies that create and sell opioids need to be held accountable for America’s drug problem, especially since several have been caught lying about the benefits and risks of their drugs. As noted by the Organic Consumers Association,⁴² the drug industry has “fostered the opioid addiction epidemic” by:

• Introducing long-acting opioid painkillers like OxyContin, which from a chemical standpoint is nearly identical to heroin, and changing pain prescription guidelines to make opioids the first choice for lower back pain and other pain conditions that previously did not qualify for these types of drugs.
• Promoting long-term use of opioids even though there’s no evidence that using these drugs long-term is safe and effective, and grossly downplaying their addictive potential. OxyContin, for example, became a blockbuster drug mainly through misleading claims that Purdue Pharma knew were false from the start.⁴³

Now, adding insult to injury, drug companies are trying to cash in on the opioid addiction crisis by pushing for legislation to combat the epidemic with, you guessed it, other drugs. NPR recently reported how Alkermes, a company that makes the anti-addiction medication Vivitrol — a monthly injection that costs about $1,000 per shot — is trying to weasel its drug into state laws, making it the sole treatment recommended for opioid addiction. NPR writes:⁴⁴

“Two years ago, a mental health advocate named Steve McCaffrey stood at a podium in the Indiana statehouse, testifying in favor of an addiction treatment bill … His brief testimony appeared straightforward. ‘We rise in support, urge your adoption,’ said McCaffrey. He said the legislation would move the state ‘toward evidence-based treatment.’ But the bill wouldn’t do that.

Instead, it would cement rules making it harder to access certain addiction medications — medications that many patients rely on. The goal was to steer doctors toward a specific brand-name drug: Vivitrol … State Rep. Steve Davisson, the bill’s sponsor, says McCaffrey helped write the bill … But there was something important that Davisson and other lawmakers didn’t know about him.

State lobbying records show that McCaffrey lobbies for Alkermes, the company that makes Vivitrol …  McCaffrey’s work … is part of a larger pattern … [I]n statehouses across the country, and in Congress, Alkermes is pushing Vivitrol while contributing to misconceptions and stigma about other medications used to treat opioid addiction …

While policymakers are grasping for solutions to the nation’s opioid epidemic, Alkermes … is using policy to promote its drug and, in some cases, hamper access to medications that can help. And in so doing, it’s looking to turn its drug into a blockbuster.”

Industry Regulations Hamper Legal Recourse

A growing number of U.S. states,⁴⁵ counties and even individual cities have filed lawsuits against opioid manufacturers for their role in creating the addiction crisis. Unfortunately, it’s proving to be extremely difficult to hold drug companies accountable for their actions. As reported by Reuters,⁴⁶ “The industry’s highly regulated nature could pose a hurdle to their success.” Since opioids, like all drugs, are regulated by the U.S. Food and Drug Administration (FDA), drug companies simply lean on the drugs’ FDA approval.

“In their view, judges and juries could defer to the agency’s approval of the companies’ opioid products as safe and effective for treating chronic pain and of the drugs’ warning labels that disclosed addiction-related risks,” Reuters notes.

“Carl Tobias, a professor at Richmond School of Law, said FDA-approved warning labels and the role of doctors in prescribing medication can insulate pharmaceutical companies from liability for failing to warn of a drug’s risks. But he noted Ohio’s lawsuit claimed the companies used advertising in medical journals and marketing presentations to downplay the risks of opioids.

In announcing the lawsuit, Ohio Attorney General [Mike] DeWine argued the drugmakers’ deception continued ‘despite the warnings in the small print of their very own drug labels and package inserts which clearly contradict their marketing.’ ‘You can give a great warning but undercut it, and that can go to the fraud point,’ Tobias said.”

Drug companies are also arguing that state and local governments should not be allowed to use private lawyers when filing these kinds of lawsuits against them. Private attorneys typically receive a percentage of the settlement, and drug companies have argued that hiring private lawyers rather than using public servants violates their constitutional rights to due process. This ridiculous argument has already worked once.

Last year, a judge invalidated the law firm Cohen Milstein Sellers & Toll’s agreement to represent former New Hampshire Attorney General Joseph Foster in his lawsuit against Actavis Pharma, Endo Pharmaceuticals, Janssen Pharmaceuticals, Purdue Pharma and Teva Pharmaceuticals.⁴⁷ The ruling effectively prevented the state from filing suit, since no “public servants” with the prerequisite legal skills are available to run the case.