The Centers for Disease Control and Prevention (CDC) has been accused of bowing to drug industry pressure after releasing new guidelines that doctors say put lives at risk by rowing back on warnings about the dangers of opioid prescribing.
The latest CDC guidelines have caused controversy after dropping specific limits on dosages and lengths of prescribing from a key summary of recommendations used by physicians.
Dr Kenneth Scheppke, Florida’s deputy health secretary, was so disturbed he issued a public statement accusing the CDC of “tossing aside” the limits used in the previous guidelines released six years ago. Scheppke told the Guardian he is concerned that the move could cost lives as the US continues to grapple with the worst drug epidemic in its history, driven by opioids.
“It’s pretty clear to me that they soften some really good, strong recommendations that they had in 2016 warning prescribers against over prescribing these opioids, and I don’t really see a good reason for removing those two warnings,” he said.
“The United States already has the highest per capita opioid prescriptions in the world, and our overdose numbers certainly reflect that. My concern is the apparent softening of the warning to my colleagues across the nation of the dangers of prescribing either for too many days or to a higher dose. That doesn’t really help the pain but raises dramatically the risk of overdose and death.”
Dr Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, sees the drug industry’s hand behind the change. Kolodny has testified against opioid makers in legal actions over their part in driving the opioid epidemic by pushing sales with false claims about their safety and effectiveness.
They include Purdue Pharma, manufacturer of OxyContin, a powerful narcotic pill that kickstarted the US’s opioid epidemic alongside the company’s marketing strategy to see the drugs widely prescribed.
Kolody said court documents show that the drug industry calculated how much the 2016 CDC guidelines would cost it if doctors followed the recommendations to limit prescribing of high dosage pills.
“The highest dosage products have had the highest profit margin. It only costs a few extra pennies to make the higher dosage pill, but retail it’s almost double what they get per pill or prescription. So the industry fought very hard to block the release of the 2016 guideline and when that failed they did everything they could to make the guidelines appear controversial. And that worked,” he said.
The latest CDC guidelines, released last month, come as the US continues to grapple with tens of thousands of opioid overdose deaths every year, as well as the consequences of addiction for others hooked on the drugs and their families.
The biggest killer today is the potent artificial opioid, fentanyl, in its illegally manufactured form. It was linked to the deaths of more than 70,000 Americans last year. More American adults under the age of 45 die from drug overdoses than in the combined toll of car accidents and suicide.
But prescription opioids drove the US opioid epidemic for more than a decade, and continue to claim lives.
The CDC’s 2016 guidelines were intended to prevent more Americans from becoming addicted to prescription drugs and to stem the flow toward illicit opioids such as heroin and fentanyl. They set recommended limits for dosages and how long opioids should be prescribed for.
Those limits remain deep in the body of the latest guidelines but are excluded from what are known as the “box three recommendations”, a summary of the guidance which Scheppke said is all most doctors read.
“They won’t get all that great background information buried in the text that points out the scientific realities that dosage above a certain level provides minimal benefit, but much higher risk of overdose and death,” he said.
“The 2016 guidelines gave physicians recommendations saying that if you are prescribing for acute pain for less than three days that’s generally reasonable. Rarely will you need more than seven days.”
That direct warning is absent from the recommendations in the latest document.
Scheppke also took issue with the latest warning that opioids “carry considerable potential risk”.
“There is nothing potential about it,” he said, noting that the earlier guidelines stated flatly that the risk existed.
Kolodny said that from the beginning the drug industry resisted official curbs on opioid prescribing.
“In 2016, it was especially important because the drug industry marketing disguised as medical education for many years had pushed this notion that there’s no upper dose limit on opioids, that you should just go as high as anybody needs. So it was really needed,” said Kolodny.
“That upper dosage limit in the 2016 guideline was what was most concerning to industry.”
In 2018, Senator Claire McCaskill released a report detailing how opioid manufacturers spent millions of dollars funding front groups, including to oppose the original CDC guidelines. Purdue Pharma gave $500,000 to the Washington Legal Foundation, which previously defended the tobacco industry, to launch a court challenge to them.
Kolodny said that when that didn’t work, the opioid industry attacked the CDC guidelines by saying they were driving patients to suicide because doctors were depriving patients of opioids and forcing them to live with unbearable pain.
Both Scheppke and Kolodny question that claim while acknowledging that there is a very real problem of patients who were dependent on high dosages of opioids who require treatment for dependency and withdrawal. Kolodny said that drove some in withdrawal to kill themselves but the drug industry has used front groups to overstate the number of deaths and to spin them as a result of lack of pain treatment in a bid to pressure the CDC to relax its guidelines.
“This is a really serious issue. But what the opioid advocates, many with industry ties, disclosed or undisclosed, pushed was this false narrative about an epidemic of suicide and so there was a manufactured backlash against the CDC guidelines,” he said.
“The notion that there are patients losing access to an effective treatment, and therefore they have no choice but to kill themselves because they’re in so much pain now, that’s a hoax. But the idea that someone in the context of acute withdrawal would kill themselves, that certainly could be real because it’s so excruciating.”
Scheppke said that what is required is not weakened prescribing guidelines but better treatment for people dependent on opioids.
The CDC has been contacted for comment.