Published: Dec 11, 2013
By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
Attorneys general from 28 states have asked the U.S. Food and Drug Administration to reconsider its approval of the powerful narcotic painkiller known as Zohydro (hydrocodone bitartrate).
In October, the FDA went against the recommendation of its own advisory committee and approved the drug, which will be the first hydrocodone-only drug in America. Hydrocodone is the opioid in drugs such as Vicodin which also include over-the-counter pain relievers such as acetaminophen or ibuprofen.
Zohydro ER will come in doses packing five to 10 times more heroin-like narcotic than traditional hydrocodone products. In addition, because it is designed to be released slowly over 12 hours, pleasure-seekers will be able to crush it, chew it, or mix it with alcohol to unleash its full punch at once because the drug does not have an abuse-limiting formulation.
In their letter to FDA Commissioner Margaret Hamburg, the 28 attorneys general said they did not want a repeat of the recent past when potent painkillers entered the market without abuse-deterrent formulas.
"This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors overprescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives," they wrote.
They said they wanted the FDA to reconsider its decision or to set a "rigorous time line" for Zohydro to be reformulated with abuse-deterrence.
Morgan Liscinsky, a spokesperson for the FDA, said the agency will review the letter and respond directly to the states' attorneys general.
The FDA's decision to approve Zohydro was the subject of a Journal Sentinel/MedPage Today investigative report that pointed to a November 2012 memo from the FDA's own staff warning that the drug will be abused more than traditional hydrocodone products. The memo compared what likely will occur with Zohydro to what happened with extended-release, oxycodone-containing opioids.
The most famous oxycodone product, OxyContin, for years was one of the most abused narcotics in America. In 2010, its maker, Purdue Pharma, reformulated its product to make it abuse-resistant.
Another Journal Sentinel/MedPage Today investigative report from October documented how, for years, FDA officials and executives of companies that make pain drugs held annual private meetings at expensive hotels through an organization funded by the drug companies. That article was based on emails obtained through public records requests and provided to the Journal Sentinel/MedPage Today.
One initiative that sprang from those meetings was a new FDA policy on how to conduct clinical trials of drugs. The new method, known as enriched enrollment, allows drugs companies to weed out people who don't respond well to a drug or who can't tolerate taking it before the actual clinical trial begins.
The approach has been described as cheating. Experts say that approach makes it much more likely a drug will prove effective and possibly win FDA approval. It's also cheaper for drug companies to conduct such trials.
Zohydro was approved using the enriched enrollment method.
The FDA approved the drug despite an 11-2 vote by its own advisory committee recommending that it not be approved.
"I am glad to see Attorneys General making their case directly to the FDA, but if the agency doesn't respect its own committee of experts, I doubt a letter will change their decision," said David Juurlink, MD, PhD, director of pharmacology and toxicology at the University of Toronto.
Jack Conway, the attorney general in Kentucky, a state that has been hit hard by opioid abuse, said that for decades it has fought the disastrous effects of the illegal marketing of the drug OxyContin.
"Zohydro ER has the potential to exacerbate the prescription pill epidemic, and given that abuse-deterrent properties are capable of being developed and required, the FDA's decision to approve the drug doesn't make sense," he said.
The U.S. already consumes 99% of the hydrocodone used in the world.
In 2010, Vicodin was the most prescribed medication in the U.S., with 131 million filled prescriptions. That same year, more than 16,000 people died of overdoses from narcotic painkillers, up from about 4,000 in 1999.
Vicodin comes in doses of 5, 7.5 and 10 mg of hydrocodone along with 300 mg of acetaminophen. Zohydro will come in six doses: 10, 15, 20, 30, 40 and 50 mg.
Kristina Fiore, MedPage Today, contributed reporting to this story.