Did mismarketing of opioid lead to addiction epidemic?


RICHMOND, Va. (WRIC) — Oxycontin, a powerful painkiller, hit the market two decades ago with bold promises, including 12-hour relief for chronic pain. Some of those promises, however, may have been false and deceptive.

“I was 20 and I was in a bad car accident,” recalled Nate Dobler who was rushed to the hospital with several broken bones eight years ago.

After numerous surgeries, Dobler was prescribed opioids to ease his pain. Eventually, he ended up taking Oxycontin, the drug that touted 12-hour pain relief. But for Dobler, the relief only last half as long as promised. “For me..it was probably 6 hours or so and it would wear off, the pain would

“For me, it was probably six hours or so and it would wear off, the pain would come back,” Dobler explained.

If he waited to take another pill, he became physically ill. He said he started to get physical withdrawal symptoms like cold chills and cold sweats within eight to 10 hours of taking the pill.

Dobler’s story is similar to what Dr. James Thompson, founder of Clean Life Medical in Henrico, was hearing from his patients.

“The medicine just doesn’t seem to be working anymore,” Thompson said.

A recent LA Times investigation found internal documents showing the drug maker Purdue Pharma had been warned soon after the drug hit the market that it was wearing off in eight hours. The paper also reported there were clinical trials showing patients were not getting 12 hours of relief. Still, the drug maker kept on with the 12-hour campaign.

“The widespread opioid abuse an addiction is partly the consequence of that campaign,” Thompson said.

Wanting to be pain-free, patients started taking the pills more frequently, exposing them to addiction. Oxycontin is a chemical cousin of heroin. Many doctors with good intentions, wanting to keep patients happy, were prescribing more.

“We are taught that it is wrong to under treat pain,” Thompson said. “I think that we have to accept that we are somewhat responsible for this.”

In 2007, Purdue pleaded guilty to a felony charge of illegally misbranding Oxycontin, but the damage may have already been done.

“We have become the United States of Oxy,” Massachusetts Senator Edward Markey said.

Markey says the drug manufacturer continues to make questionable claims about the longevity of the drug. The label still promotes 12-hour dosing. The senator has now called on the Department of Justice and FDA to investigate.

Purdue Pharma rejects the claims made by the LA Times, telling 8News:

Purdue Pharma rejects the claims made by The Los Angeles Times (LAT) in “OxyContin’s 12-Hour Problem.” In an attempt to resurrect a long-discredited theory, the paper ignores the clinical and regulatory data that directly contradicts their story.

Over the course of two years, Purdue Pharma provided the LAT with more than a dozen hours of briefings and discussions regarding the clinical evidence supporting OxyContin’s 12-hour dosing and the regulatory requirement that we promote the product as such. Unfortunately, the paper disregarded this information, insteadpublishing a story that’s long on anecdote and short on facts.

CLAIM: OxyContin has a 12-hour dosing “problem” that puts patients at risk.

FACT: Nearly a decade ago, the FDA cited a lack of clinical evidence when it formally rejected the “fundamental premise” that patients receiving OxyContin at intervals more frequent than twice-daily are at increased risk of “side effects and serious adverse reactions.” In doing so, the agency reinforced the twice-daily labeling for OxyContin. The LAT omitted the findings of this report from its story.

CLAIM: The clinical data shows OxyContin is “an 8-hour drug.”

FACT: Scientific evidence amassed over more than 20 years, including more than a dozen controlled clinical studies, supports the FDA’s approval of 12-hour dosing for OxyContin. The OxyContin label has been updated more than 30 times and at no point did FDA request a change to the dosing frequency. In fact, the FDA-approved label clearly states, “There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.”

CLAIM: Purdue should tell physicians to prescribe OxyContin for eight-hour use.

FACT: The FDA prohibits pharmaceutical companies from promoting their products for uses, including dosing, not approved by the agency. Given FDA has not approved OxyContin for eight-hour use, we do not recommend that dosing to prescribers. In fact, a State Attorney General recently cited a peer company for falsely claiming that OxyContin was an eight-hour drug. The LAT omitted this piece of information from its story.

The FDA says:

These are not simple issues and there are no easy answers. Given the complexity of this issue, real and enduring progress will require a multi-faceted approach combined with the dedication, persistence and full engagement of all parties. 

Understanding the appropriate dosing interval is an important part of prescribing any drug safely because each patient may respond differently to medication. Our goal when developing a drug label is to include the necessary information about a drug’s safety and efficacy so that trained physicians can use this information and their medical expertise to make informed decisions for their patients. In additional to labeling information, doctors rely on their medical training and understanding of the disease and medication effects as well as their patients’ response to the medication’s effects, when developing a treatment plan.

With this in mind, and as part of our larger work to improve the appropriate prescribing of opioids, we will continue to evaluate the labels for extended-release opioids, including OxyContin, to ensure they contain the essential information about the use of these drugs, and will revise labeling as necessary to improve proper prescribing and treatment.

Additionally, we want to underscore the context regarding the individual variability of the dosing interval – here is some background:

Our goal when developing a drug label is to include the necessary information about a drug’s safety and efficacy so that trained physicians can make informed decisions for their patients. The 12-hour dosing interval for OxyContin included in the label is derived from OxyContin’s clinical trials. It also reflects a delicate balance between assuring pain relief and avoiding withdrawal before the next dose is due and avoiding toxicity and even overdose. It should be well understood by physicians that there will be some individual variability in the length of time that patients respond to this drug – as with all drugs – and so, while the labeled dosing regimen is a reasonable starting point, physicians should carefully individualize their approach to patients based on how quickly they metabolize the drug. (Please note, from the current label: “The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance.”)

Additionally, it’s important to reinforce that the label clearly states that OxyContin should only be used in patients for whom alternative treatment options (e.g. non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

The FDA is deeply concerned by the way opioids are prescribed and used in this country. Additional prescriber education can help prescribers in the proper use of opioids to treat patients in pain. This is one of the many reasons that FDA required a risk evaluation and mitigation strategy (REMS) in 2012 that requires the manufacturers of the extended-release/ long-acting opioid pain products to make prescriber education available. These programs have been made available to prescribers at low or no cost through Continuing Education (CE) providers and we continue to evaluate how that program is working. In addition, prescriber education is one of the pillars of the broader federal response to this epidemic that was announced by the Secretary of HHS in March 2015.

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