The Centers for Disease Control and Prevention (CDC) has issued its anticipated new guidelines for prescribing opioids, a move the agency hopes can help reduce the rate of addiction in the U.S. to the powerful painkillers, but which also will have the effect of further dampening sales of the drugs.
|CDC Director Tom Frieden
The new rules, which are voluntary, are aimed at the frontline of healthcare: the primary care physicians, physician assistants and nurse practitioners who write the majority of opioid prescriptions. They recommend that for short-term pain, clinicians first try alternatives such as nonsteroidal anti-inflammatory drugs along with physical therapy. If they prescribe opioids, the CDC suggests first giving the minimum dose and to prescribe only three days' worth of pills. The guidelines don't apply for patients getting pain drugs for cancer or who are receiving end-of-life care.
"Overprescribing opioids--largely for chronic pain--is a key driver of America's drug-overdose epidemic," CDC Director Tom Frieden, said in announcing the guidelines. "The guideline will give physicians and patients the information they need to make more informed decisions about treatment."
The rules came in response to the recognition that rampant use of opioids has led to a growing rate of addiction to the prescription pills as well as resurgence of heroin, which many addicts turn to because it is cheaper. It has also meant a growing rate of death from overdoses. According to CDC stats, the rate of drug overdose deaths from prescription opioids and heroin tripled between 2000 and 2014.
The addiction problem has become the focus of an expansive public policy debate with politicians, law enforcement officials and anti-addiction groups often blaming drugmakers for feeding the problem with aggressive marketing and federal agencies for not taking the problem seriously.
|FDA Commissioner Robert Califf
Last month, now FDA Commissioner Robert Califf responded the criticism of the agency by calling for a sweeping re-examination of its policies on approving opioids. He laid out an 8-point plan that he said would "focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief."
But some of the backlash has been in the form of litigation. Lawsuits have been filed in Chicago and California by governments against drugmakers as authorities have tried to make them take some responsibility for what has been termed an epidemic of opioid abuse in the country. They accuse drugmakers of aggressive marketing while playing down the risks of the powerful painkillers. A number of other states are investigating the marketing methods of some companies. Last week, Endo Health Solutions ($ENDP) settled litigation with the New York Attorney General over its Opana ER painkiller, agreeing to pay $200,000 and take a variety of steps to make sure doctors understand the addiction risks to their patients.
Corey Davis, a senior specialty pharmaceuticals analyst at Canaccord Genuity, told the Wall Street Journal that while the CDC guidelines are likely to depress sales of opioids, drugmakers have already seen a downward trend in revenues as doctors wrote fewer prescriptions in response to concerns about addiction. Most prescriptions are for generic versions of the drugs.
OxyContin maker Purdue Pharma declined to comment on the guidelines to the Wall Street Journal, saying only that they "are part of the clinical decision-making process, which should be determined by therapeutic area experts and other relevant stakeholders." The company noted its products currently account for less than 2% of the total opioid prescriptions written.