fda

FDA Reexamining Opioids For Chronic Pain

/ Thomas Cohn, MD

FDA effectivenessThe Food and Drug Administration has announced that it will require drug companies to conduct studies to determine if prescription opioids are effective in treating chronic pain.

A number of studies have already suggested that pain controlling opioids are ineffective beyond 12 weeks, and many industry professionals say that continued opioid use after this period can increase a person’s likelihood of developing a dependence or addiction. The FDA wants to supervise the new studies to determine if certain changes, like the following, need to be made:

  • Changing the labeling on certain opioids
  • Imposing special rules for prescribing, dispensing and taking certain opioids
  • Prohibiting use of certain opioids in some cases

“We are going to impose a mandate on existing products . . . to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” said FDA Commissioner Scott Gottlieb.

Some Don’t Agree

While it may seem like a good move that the FDA is appearing to take a step in the right direction of opioid abuse, others say the new measures are nothing more than a stall tactic for big pharma. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA ordered a similar measure in 2013 and that they already have all the research they need to make changes that could help protect the public.

“Here we go again,” Kolodny said in an interview. “That’s exactly what the FDA said to us in 2013. . . . Five years later, we don’t have the studies and another FDA commissioner says, ‘We’re going to do the studies.’ ”

However, Gottlieb argued that the research would be aimed at immediate, extended-released and long-acting opioid tablets that are given for pain care outside the healthcare facility. The studies would also cover current medications on the market to examine if new applications of the pain reliever could be more effective. The FDA will also be conducting a second study that is out to determine if opioids can actually cause users to become more sensitive to pain.

A similar study was carried out back in 2013, but Gottlieb said those studies were difficult to carry out because the FDA could only ensure post-marketing studies on safety, not effectiveness. They now have the authority to demand effectiveness research as part of an act passed back in October.

The opioid crisis killed 47,600 people in 2017, but there’s hope that the new research can lead to effective changes. There’s still plenty of work to be done, but with more control over effectiveness research, there’s hope on the horizon.

FDA Increases Rules for Opioid Prescribing to Cut Down on Abuse

/ Thomas Cohn, MD

opioid perscriptionThe FDA recently decided to tighten the labeling requirements for opioid medications.  Over the past decade, opioid medications have become increasingly prescribed for pain conditions.  Unfortunately, these medications have also become highly abused in the US.  From multiple fronts, there has been a push to control the use of opioids and improve their safety.

A Brief History of Opioids

Opioids are strong analgesic medications used for a variety of pain control situations.  Initially, they were used to treat short-term, acute pain related to surgery, injury, and illness.  Eventually, opioids also became a pain relief option for terminal illnesses such as cancer.  As pain became a concern in quality of life, and considered a “fifth” vital sign, opioid medication prescriptions blossomed.  As opioid popularity increased, opioid prescription abuse also swelled.  Now both the FDA and DEA are working to stem abuse and improve the appropriateness of prescribing by physicians.

Opioid Abuse and Pain Management

Pain is extremely challenging to manage and treat.  The complexity of pain has spawned it’s own medical specialty – Pain Management. Twenty years ago, finding a physician who knew anything about pain management was a rarity.  Currently, there are some pain specialists, but still very few board certified specialists in the US.  Medical school training programs still do not have formal pain education, and most medical residencies have no pain medicine training or experience at all.  Pain fellowships train only a small number of physicians yearly.

Pain management is complex, requiring specialized knowledge, and the ability to find a variety of solutions for difficult problems.  Opioid medications have been easy to prescribe and often a simple solution to a variety of pain problems. The FDA is trying to change the wave of opioid use through changing the labeling of medications, warning physicians and patients that these drugs may be dangerous.  Unfortunately, this is likely to be an overly simplistic solution to a complex problem.

A Better Solution to Opioid Abuse

Improving opioid prescribing is important, but the better starting point may be improving the understanding of pain by doctors as well as patients.  Doctors need more training, starting in medical school and progressing throughout residency and practice.  Patients would also benefit from the help of physicians trained and specializing in pain medicine.  Pain is complex and opioids are only a small part of a solution.  It will take multiple efforts to decrease opioid abuse, and improve appropriate prescribing. The FDA is starting the effort, but it will require concerted effort by doctors and the medical community to increase knowledge of opioid use and its potential dangers.