March 17, 2014

FDA action on drug falls short of protecting public | Huntington Herald Dispatch

The U.S. Food and Drug Administration's approval of a powerful new painkiller is akin to adding fuel to a fire that's already burning out of control.

In this case, the inferno is what the FDA itself has described as the "abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

Yet, coming to market next month is a prescription drug called Zohydro ER. Its only ingredient is the highly addictive hydrocodone, one of the most commonly prescribed and abused prescription drugs in America. The FDA's approval late last year allows for dosages of five times or more than now prescribed for such popular painkillers as Vicodin, which also contains hydrocodone.

To many health advocates, lawmakers and law enforcement officials across the country, the FDA's action didn't make sense. Many are urging the FDA to revoke its approval of the drug.

In December, attorneys general from 28 states, including Kentucky, wrote to FDA Commissioner Margaret Hamburg urging reconsideration of the approval because they feared more trouble like what followed the release of potent painkillers in the past -- "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.

This week, a coalition of more than 40 health care, consumer and addiction treatment groups put forth the same arguments in urging the FDA to reverse its decision. They have good reasons for their concerns: Prescription opioid deaths in the country totaled more than 16,600 in 2010, more than four times the total just 11 years before. West Virginia and Kentucky knows the deadly toll all too well; those states have the highest and third highest overdose mortality rates in the nation.

Zohydro's maker, as well as the FDA, say a need exists for the single-ingredient drug to help certain patients deal with pain severe enough to require daily, around-the-clock, long-term treatment. Other combination drugs containing hydrocodone pose problems for long-term use because other ingredients in them -- such as acetaminophen -- pose other health dangers, they said.

However, the FDA's approval of Zohydro is fraught with problems.

Critics note that the formulation approved for Zohydro does not have any abuse deterrents, something that the FDA has pressed other painkiller manufacturers to do and is considering making a requirement for such high-potency drugs. That means the pill can be easily crushed, snorted or injected by abusers. Zohydro's manufacturer said it may be three years before such an abuse-deterrent formulation will be completed.

It also happens that an FDA advisory panel voted 11-2 to recommend against approval, citing concerns about addiction to opioid drugs.

Others, including Sen. Joe Manchin, D-W.Va., also have raised questions about whether a "pay-to-play" conference in which pharmaceutical company representatives paid to meet with FDA regulators had a role in the eventual approval of Zohydro.

The FDA and Zogenix Inc., the company that sought Zohydro's approval, say new safeguards for opioid drugs will prevent abuse. A company spokesman says the company will focus its marketing efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.

However, past experience shows that drug manufacturers show little restraint when it comes to marketing their products. And there is no track record as of yet to show whether the new FDA safeguards against abuse are effective.

With that lack of evidence, and the failure to require the drug to be made in a formula that deters abuse, the FDA should withdraw its approval of Zohydro until those factors are more fully sorted out. Otherwise, the FDA is simply aggravating a problem that already is far, far too severe.

Let’s not vote for the business-as-usual, again.

By:  Editorial