In response to a backlash against her bill imposing a nationwide seven-day limit on initial prescriptions of opioids for acute pain, Sen. Kirsten Gillibrand (D-N.Y.) suggests she is open to changes that would address the concerns raised by critics. Gillibrand's acknowledgment of the criticism is encouraging, but her response seems confused, wrongheaded, and disingenuous.
"I want to get this right," the presidential contender writes on Medium, "and I believe that we can have legislation to help combat the opioid epidemic and the over-prescription of these powerful drugs without affecting treatment for those who need this medication. I fundamentally believe that all health care should be between doctors and patients, and this bill is not intended to interfere with these decisions but to ensure doctors prescribe opioids with a higher level of scrutiny, given their highly addictive and dangerous effects."
If "legislation to help combat the opioid epidemic" includes an arbitrary limit on the length of these prescriptions, there is no way that it won't affect "treatment for those who need this medication." It is impossible to reconcile such a one-size-fits-all rule, which doctors would have to follow if they want to legally prescribe controlled substances, with Gillibrand's avowed commitment to not "interfere" in the doctor-patient relationship. Her bill, which is co-sponsored by Sen. Cory Gardner (R-Colo.), is designed to interfere in that relationship and to override physicians' medical judgment. If it did not do that, there would be no point to it.
To be fair to Gillibrand, she did not invent the seven-day rule, which at least a dozen states have imposed in the last few years, according to a tally by National Conference of State Legislatures. Several others have imposed shorter limits. Legislators in Arizona, New Jersey, and North Carolina have decreed that five days is plenty; Minnesota settled on four; and Florida and Kentucky say three, which is the national rule that Sen. Rob Portman (R-Ohio) proposed last year, prompting criticism from the American Medical Association. Medicare began enforcing a seven-day limit at the beginning of this year.
These legislators and bureaucrats all seem to be taking their cue from the opioid prescribing guidelines that the U.S. Centers for Disease Control and Prevention (CDC) published in March 2016. "When opioids are used for acute pain," the CDC says, "clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed." Legislation like Gillibrand's takes this advice and makes it mandatory, while ignoring the qualifications. Saying that three days is "often sufficient" obviously does not mean it is always sufficient, and even if more than seven days is "rarely" needed, it sometimes is.
A study reported last year in JAMA Surgery found that the prescription length associated with the lowest probability of a refill was nine days for general surgery, 13 days for women's health procedures, and 15 days for musculoskeletal procedures. "In practice," the researchers concluded, "the optimal length of opioid prescriptions lies between the observed median prescription length and the early nadir," i.e., the point where a refill was least likely.
That rule of thumb would put the optimal prescription length between four and nine days for general surgery, between four and 13 days for women's health procedures, and between six and 15 days for musculoskeletal procedures. "Although 7 days appears to be more than adequate for many patients undergoing common general surgery and gynecologic procedures," the researchers wrote, "prescription lengths likely should be extended to 10 days, particularly after common neurosurgical and musculoskeletal procedures, recognizing that as many as 40% of patients may still require 1 refill at a 7-day limit."
There is no dispute that doctors sometimes prescribe more pain medication than patients end up needing, and leftover pills from those prescriptions may be diverted to nonmedical use (or saved in case they are needed for another painful condition, which the government still considers "misuse," although someone who takes a pill originally prescribed after oral surgery when he throws out his back would probably disagree with that characterization). Bills like Gillibrand's force doctors to err in the opposite direction, which means some patients will suffer from pain that could have been relieved. And even if some of those patients manage to get additional prescriptions, the upshot could be that more pills are prescribed than otherwise would have been: two seven-day prescriptions, say, instead of the 10 days that would have sufficed.
"Most acute pain doesn't need more than seven days," says Lynn Webster, a former president of the American Academy of Pain Medicine. But while "there's clearly been more prescribed than has been necessary" in many cases, Webster says, seven days is "an arbitrary number" and "not sufficient for a large number of patients."
After some surgeries and traumatic injuries, Webster says, patients "end up having a need for far more than seven days," and "in many cases, these are people that can't easily get back into the doctor's office." He notes that "these are Schedule II drugs, so you can't call it in." If the initial prescription is legally limited to seven days, "you're going to have to stretch it out or otherwise you're going to be without analgesic."
Clinical pharmacist Jeffrey Fudin agrees that seven days will be too short for some patients with acute pain caused by major surgeries or by injuries such as compound fractures. "Imagine if you had your pancreas taken out," he says. "I mean, come on. It's going to be more than a week of pain for certain."
Gillibrand's bill makes an exception for patients with chronic pain (as well cancer patients and people in hospices or palliative care). But people who suffer from chronic pain worry that the distinction is not always clear, especially when you begin care or switch to a new doctor. "The distinction between chronic pain and acute pain isn't nearly as neat and tidy as the Gillibrand and Gardner press release indicates," Matthew Cortland, a chronic pain patient and disability rights lawyer, told The Huffington Post. "The patient community knows that for many living with pain, it can take months or years to get a correct diagnosis of chronic pain."
Gillibrand evidently thinks these burdens are justified by the goal of preventing addiction to pain pills that turn out to be medically unnecessary. "If we want to end the opioid epidemic, we must work to address the root causes of abuse," she wrote on Twitter last week. "One of the root causes of opioid abuse is the over-prescription of these powerful and addictive drugs," she says in the press release she issued along with Gardner.
The idea that leftover pain pills are a "root cause" of substance abuse is fundamentally mistaken. If these pills were as "highly addictive" as Gillibrand says, they would not be left over to begin with. The fact that partial prescriptions from old surgeries and injuries can be found in medicine cabinets throughout the country tells us that exposure to these drugs usually does not result in addiction. According to the National Survey on Drug Use and Health, about 2 percent of the nearly 100 million Americans who used prescription opioids in 2015, including nonmedical users as well as patients, qualified for a diagnosis of substance use disorder that year. By comparison, NSDUH data indicate that 9 percent of past-year drinkers had an alcohol use disorder in 2015.
People do not become addicted to opioids simply because they are there; they become addicted because of pre-existing personal, social, and economic circumstances that make these drugs appealing. The "root causes" of drug addiction are misery, anxiety, and despair, not half-finished bottles of hydrocodone. "Oftentimes," Gillibrand says, "the first over-prescription spurs the devastating path of addiction." But studies of patients find that people rarely become addicted in the course of bona fide medical treatment. Nonmedical users typically do not obtain pain pills from prescriptions written for them, and opioid-related deaths generally involve polydrug consumers with histories of substance abuse and psychological problems.
"Each day," Gillibrand's press release says, "41 people die from an overdose related to these prescription painkillers." She is referring to the 14,500 deaths involving "natural and semi-synthetic opioids" that the CDC counted in 2017. Yet according to the records collected by the CDC, more than 90 percent of those deaths involved combinations of drugs, and the true number may be even higher. In New York City, which has one of the country's most thorough systems for reporting drug-related deaths, 97 percent of them involve mixtures. And although Gillibrand portrays her bill as a response to the "opioid crisis," 75 percent of the opioid-related deaths reported by the CDC involved illegally produced drugs such as heroin and fentanyl.
Even if it were morally acceptable to sacrifice the interests of patients for the sake of preventing opioid-related deaths, there is little reason to think Gillibrand's bill would achieve that goal. Not only is she focusing on drugs that account for a small share of opioid-related fatalities, but her bill could increase the death toll by driving more nonmedical users into the black market, where the drugs are much more dangerous because their potency is highly variable and unpredictable. That kind of substitution helps explain why reductions in opioid prescriptions have been accompanied by a surge in opioid-related deaths.
In any case, it is not morally acceptable to sacrifice the interests of patients in the name of preventing opioid abuse. That kind of collectivist calculus has no place in a free society that treats people as individuals, a society in which "all health care should be between doctors and patients," as Gillibrand puts it. If she really meant what she says, she would not be trying to replace their judgment with hers.