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Minnesota doctors among those urging FDA to limit use of prescription painkillers

Oxycodone pills
CC/Flickr/Be.Futureproof
Minnesota physicians have joined others seeking to prevent addiction to painkillers like oxycodone.

Three Minnesota physicians who specialize in treating pain and addiction are among 37 clinicians, researchers and health officials who petitioned [PDF] the U.S. Food and Drug Administration Wednesday to change the labeling of prescription opioids.

The goal of their request: to prevent more people from becoming addicted to these powerful painkillers, which include such drugs as oxycodone (Oxycotin) and hydrocodone (Vicodin).

The petition asks the FDA to take three specific steps: 1) to no longer indicate that opioids can be used for “moderate” pain, 2) to add a maximum daily dose for the drugs (the equivalent of 100 milligrams of morphine), and 3) to put a limit (90 days) on the amount of time a patient can take these painkillers. All of these changes would be for non-cancer pain.

Dr. Charles ReznikoffDr. Charles Reznikoff

“When the FDA indications for opioid pain medications were written [in the 1990s], there was no good science backing up what they said, but I don’t fault them for that,” said Dr. Charles Reznikoff, one of the petitioners and an addiction specialist at the Hennepin County Medical Center, in a phone interview.

“Now, though, we know the risks,” he added, “and it’s a good time to reevaluate that opinion.”

The other two Minnesota physicians who signed the petition are Dr. Miles Belgrade, medical director of the Fairview Pain Management Center in Minneapolis, and Dr. W. Michael Hooten, an anesthesiologist and pain specialist at the Mayo Clinic in Rochester.

A major health problem

The health burden associated with opioid addiction is significant. Prescription drug abuse is now the fastest-growing drug problem in the U.S., according to the Centers for Disease Control and Prevention. Since 2003, more people have died from prescription-drug overdoses than from overdoses of heroin and cocaine combined.

“It’s truly a nationwide epidemic, and there are almost no demographics — age, race, gender, state, rural or urban or suburban — that are exempt from it,” said Reznikoff.

The annual death rate from prescription-painkiller overdoses in the U.S. is 12 per 100,000 people, according to Reznikoff. “That’s comparable to motor vehicle deaths and suicide deaths,” he said.

Here in Minnesota, the annual death rate is slightly lower — about 8 or 9 people per 100,000. The percentage of Minnesotans abusing pain medication is also lower — 4.8 percent compared with 5.5 percent nationally, according to Reznikoff.

“We’re prescribing it less. We’re abusing it less. And we’re overdosing less than other states in the nation,” said Reznikoff. “But that doesn’t mean it isn’t a problem for us."

Doctors inadequately educated

As Reznikoff and the other health professionals point out in their petition to the FDA, many doctors are under the false impression that opioids have been proven safe and effective for chronic non-cancer pain, even though no well-designed long-term studies have ever been conducted on these drugs. Such misperceptions have led to the over-prescribing and high-dose prescribing of painkillers.

Doctors are also often unaware that these drugs can become addictive relatively quickly. “Within a month, you’re often feeling withdrawal,” said Reznikoff.

This lack of knowledge about prescription painkillers stems from the fact that their widespread abuse is a relatively new health problem and, thus, isn't covered much in medical school, said Reznikoff. But that situation is changing, he added.

Reznikoff recently gave a talk about the addictive dangers of prescription painkillers at a hospital in Massachusetts. “On the way to the talk, they told me not to be surprised if only a few doctors showed up,” he said. “But so many doctors showed up, they ran out of chairs. And they stayed to the end and asked questions. So doctors are feeling hungry for information. That’s a good sign.”

Slowing the momentum

Getting physicians to change their prescribing habits regarding opioids is unlikely to happen overnight, however. Sales of prescription painkillers increased by almost 400 percent between 1999 and 2008, according to the CDC. Slowing and reversing that momentum will take some time, particularly given the huge amount of money at stake for the pharmaceutical industry.

But doctor-enthusiasm for the aggressive prescribing of opioids may soon be on the wane — and for reasons that have nothing to do with better physician education. In May, the U.S. Senate Finance Committee launched an investigation into the financial connections between the Big Pharma companies that make these drugs and the various medical groups and physicians who have been advocating their increased use.

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Comments (2)

Ignoring the obvioius

This petition, while appearing reasonable on the surface, is not supported by science. If the FDA followed their suggestion, it would only remove an entire class of painkillers from being used after 90 days, regardless of the need.

We already know from science that approximately 10% of the population who use opioid painkillers are at risk of developing an addiction, so that's hardly the rampant problem that's being depicted. What makes one person develop an addiction and the next person not is unknown at this point, but it won't be solved by taking away a class of painkillers to treat their pain, or placing an artificial limit on how long they could use them before being cut off, with no other alternative. And since these proposed changes wouldn't apply to cancer patients, they've placed them in their own little exclusion zone, even though they're just as likely to develop an addiction.

If the FDA limited their use based on generic terms such as "moderate" or "severe" pain, that's a slippery slope, since the patient is the best judge of their level of pain; some people have a higher tolerance to pain, while others have a very low tolerance. When you're in pain, your only goal is to get rid of the pain as quickly as you can. Pain is pain; it doesn't matter, nor should it matter to the doctor or the FDA whether or not you have cancer.

One of the problems of opioids is that we actually don't know how they work; we only know that they do. For example, if you have severe pain that does not respond to conventional treatments including acetaminophen or Vicodin, there's really only one thing left: Demerol. It's expensive, and only a doctor can administer it, but within a few minutes, your pain will go away. The side effects include possibly vomiting once or twice in the first 10 minutes, slower reaction times, and decreased respiration. You'll be told to go home (not drive) and go to sleep for at least 8 hours, after which you should be back to normal.

To actually reduce the number of people who become addicted to opioid painkillers, the best solution is for the drug manufacturers to develop new drugs that are not opioids but just as effective (or more effective) as the opioids currently on the market. And that means learning more about the causes of pain that can only be treated by the current lineup of opioid drugs, and how to target the pain signals from your brain, and turn them and/or the pain receptors off.

Petition opposition

Here's an interesting response to the petition from Dr. Bob Twillman, the Director of Policy and Advocacy for the American Academy of Pain Management...Dr. Twillman concludes "there is not a sufficient accumulation of high-quality studies with consistent findings to support" this petition. http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opi...