This weekly column offers opinions on the latest pharmaceutical industry news.
Every day, 44 Americans overdose and die after taking opioid painkillers. Every year, 2 million people abuse or misuse the drugs. And as addictions and deaths mount nationwide, authorities are struggling to cope.
State lawmakers are introducing bills to restrict prescribing. The Food and Drug Administration is pushing pharmaceutical companies to develop more tamper-resistant products. And in one dramatic move, the police chief of Gloucester, Mass., posted a plea on Facebook urging the public to contact drug company executives to help curb the crisis.
But arguably, the most sweeping initiative comes from the US Centers for Disease Control and Prevention, which has prepared preliminary prescribing guidelines for primary care physicians. The recommendations, outlined in a webinar in September and subsequently leaked online, call on doctors to prescribe opioids only after other therapies have failed.
This is a crucial effort. Family doctors write the vast majority of prescriptions for painkillers. And with 14 million Americans suffering severe pain each day, ensuring that these health care providers have useful guidance is critical to stemming the tide of painkiller addiction.
Yet there is considerable opposition to the guidelines — and much of the reproach comes from organizations that represent patients suffering from cancer and pain.
These critics — which include the American Cancer Society and an umbrella group of leading pain societies — say the CDC guideline process was flawed and, as a result, some patients will be denied much-needed pain relief. But experts counter that it’s the drug industry, not patients, that has the most to gain by blocking the CDC initiative.
“The criticism is hollow and comes from people who are heavily conflicted,” said Dr. David Juurlink, a clinical pharmacologist at the Sunnybrook Health Sciences Centre in Toronto and a member of Physicians for Responsible Opioid Prescribing, a nonprofit group based in New York.
Juurlink is referencing the fact that many of the professional associations and patient advocacy organizations that have been most critical of the CDC receive funding from the manufacturers of top-selling opioid narcotics. These companies — Purdue Pharma, Endo International (ENDP), and Johnson & Johnson (JNJ) — have all been accused of marketing their pills without fully disclosing the potential for addiction.
A key complaint is that some cancer patients, especially those in remission, will be denied relief under the new CDC guidelines. “They may curb some of the abuse,” conceded Christopher Hansen, president of the Cancer Action Network, the American Cancer Society lobbying arm. “But I think there will be other problems,” he said. Last month, Hansen’s organization asked the CDC to scrap the guidelines before they are completed early next year.
“The criticism is hollow and comes from people who are heavily conflicted.”
Dr. David Juurlink, Sunnybrook Health Sciences Centre
The American Academy of Pain Management, meanwhile, wrote to the Energy and Commerce Committee of the US House, asking for an investigation into the CDC process for developing the guidelines. The group said the CDC never publicized its deliberations. It also charged that the agency relied on weak data, while failing to recruit pain specialists for its expert panel.
The CDC, through a spokeswoman, said it used a “rigorous peer review process” that included input from outside experts.
The patient groups, which contend industry funding is a small part of their budgets, do make one good point. It’s true that the CDC should have had more pain specialists among the 17 outside advisers. This might have helped blunt suspicions the agency was aligning itself with Physicians for Responsible Opioid Prescribing, where Dr. Jane Ballantyne, one of the panelists, is president. Ballantyne, a retired anesthesiologist at the University of Washington, is also a paid consultant to a law firm involved in challenging drug makers on opioid marketing. (This was disclosed to the CDC.)
But the patient groups miss the mark elsewhere. According to Dr. Lewis Nelson, an emergency medicine specialist at the New York University Langone Medical Center and one of the CDC advisers, cancer sufferers who are in remission count as chronic pain patients under the guidelines. And while acknowledging that the underlying data used to make the recommendations are weak, Nelson said that’s because there isn’t a lot of evidence available to evaluate long-term use of opioids or compare them with other options, not because of any omission by him or his fellow panelists.
“This complaint is a straw man,” he told STAT.
Guidelines are needed. Right now, there is a distinct lack of direction for safe and effective opioid prescribing. After incorporating any comments, the CDC should proceed and issue its recommendations as planned in January. Blocking their release would be a mistake and lead to still more pain across the country.