In October of this year the FDA approved Zohydro ER (extended release), a pure hydrocodone product with close to 10 times the amount of heroin-like narcotic found in traditional hydrocodone products. The product has been approved in its current slow-release formulation, meaning that it can be crushed, chewed or mixed with alcohol and still retain full potency. Drugs like OxyContin have been formulated in a way that decreases the power of the drug when altered from its original form.
There are several troubling issues about the drug, Zohydro, starting with the approval process by the FDA. Andrew Kolodny, a physician and the chief medical officer of Phoenix House, which runs drug and alcohol treatment centers in 10 states, has fought for stronger restrictions on pain-pill prescriptions. He attended the recent public meeting and spoke during the public comment period. “One has to wonder how many more pain patients have to be harmed, how many more people have to become addicted, how many more lives will have to be lost,” he said, “before the F.D.A. finally begins to exercise its authority and responsibility to prohibit drug companies from marketing opioids as if they have been proven safe and effective for long-term use.”
The issue is a complex one; it is not a simple matter to withhold drug approval when similar drugs have FDA approval. Zohydro has been ruled to be as safe and as effective as other drugs in the same class. The real conversation should be focused on the whole class of painkillers. But as Bob Rappaport, the director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, points out, “We are obligated at the agency to operate within the regulatory framework,” he said, “and that includes providing a level playing field for industry. We don’t have a choice by that. It’s the law.” (The New Yorker, 12/3/13)
The other troubling issue with this new drug is the close association of the manufacturer, Alkermes, and the American Society of Addition Medicine. Alkermes also makes Vivitrol, a popular drug for the treatment of people addicted to painkillers or alcohol. Alkermes appears to have close ties to experts in the field of substance abuse, and is a financial contributor to the American Society of Addiction Medicine. So, we have a pharmaceutical company that makes highly addictive drugs making financial contributions to an association of substance abuse experts. Does this sound like, at a minimum, the appearance of a conflict of interest? Is this a closed-door alliance to maintain addictive behaviors? Is there a logical reason for Alkermes to give money to this specific group? And, how does that affect its judgment when it comes to manufacturing a extremely potent and high-addictive medication? You can answer the questions easily. It smells a little funny.
The FDA approved this drug even after its own approval panel voted, 11 to 2, against approval. And, now Attorneys General from 28 states have written a letter asking that the FDA either “reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies to impose restrictions on how Zohydro ER can be marketed and prescribed.”
One does not have to be a physician or pharmacist to see that Zohydro ER is a very powerful, dangerous drug. Did the FDA act too quickly? It certainly acted against the recommendation of its own panel of experts, which is somewhat puzzling. Why is this powerful of a drug needed? Are the current drugs we have insufficient? It is hard to imagine that our physicians do not have a sufficient selection of narcotic pain medications from which to choose. Perhaps this is another block-buster, high profit-margin drug for the manufacturer.
How frequently will doctors prescribe this medication? “In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. Hydrocodone also consistently ranks among most-abused medicines in the U.S., according to the Drug Enforcement Administration.” Only time will tell how this drug will be received and how much it will be abused. Hopefully, it does not follow a similar path of its little sister, hydrocodone.