Community Forum: FDA should limit spread of drugs

A year and a half ago, I stood up before Vermonters and devoted my State of the State address to speaking about the opiate and heroin crisis affecting our state. Despite our best efforts since, this is not a battle we are winning. Now the Food and Drug Administration is recklessly making the problem worse with its decision to approve OxyContin for use by children as young as 11 years old.
I was horrified when I learned of the FDA’s decision last month. In the past 18 months, Vermont has invested millions of dollars in battling the threat that opiate abuse poses to families and our communities. We united behind the view that addiction is primarily a health care issue and that users need treatment, not prison cells. But Vermont continues to face the enormous personal and economic toll of drug abuse, just as the rest of the country does.
Our doctors and hospitals are examining their prescription practices to limit opiate distribution. Law enforcement and the families of addicts are carrying Narcan, which can reverse the effects of a heroin or opioid painkiller overdose. Recovering addicts are visiting schools to tell their stories to young Vermonters before they choose to use. Our treatment programs are expanding, and our acceptance and support of our addicted friends, co-workers, neighbors and family members is growing. Virtually everyone is committed to doing their part to end the vicious cycle created by drug addiction.
Now is the time for the FDA to be a partner in reducing — not expanding — the availability of these drugs. Instead, it is doing the exact opposite. While it is true that there are a small number of very ill children who may benefit from the extended-release nature of OxyContin, which allows for longer intervals between doses, the risks of approving this medication for kids are great.
We know that teenagers are at a higher risk for addiction than adults because of their immature brain development. And we know that even if prescribed with the best of intentions, expanding the availability of these drugs in general has terrible consequences. It can lead to high rates of abuse, the use of other opioids such as heroin and, too often, death.
It’s unfortunate but not all that surprising that the FDA is ignoring the risks of making OxyContin more widely available. Along with the pharmaceutical industry, the FDA lit the match that ignited the addiction crisis in this country when it approved OxyContin in the mid-1990s. The irrational exuberance with which painkillers were handed out following that approval is disturbing.
According to the Centers for Disease Control and Prevention, doctors in the United States prescribed enough painkillers in 2010 to “medicate every American adult around-the-clock for a month.” Many medical experts believe that there is no reason that powerful painkillers should be so prevalent in our society. But there may be a financial one: According to Fortune magazine, opioids generated $11 billion in revenues for pharmaceutical companies that same year.
Despite the mounting addiction disaster, the FDA has apparently learned nothing. Just two years ago — the same year the Centers for Disease Control reported that more than 16,000 Americans died of opioid overdoses — the FDA approved a new opioid painkiller called Zohydro over the objection of an advisory committee. The committee, which voted 11 to 2 against approval, cited the rising tide of opiate addiction in America and the potential for Zohydro to make that problem worse.
In July, the CDC released a report that appeared to prove the advisory committee’s warnings correct. According to the findings, heroin addiction is surging across America, increasing among men and women, among most age groups and all income levels. And the strongest risk factor for heroin abuse is “a prescription opioid use disorder.”
Now the FDA has taken it a step further by approving this poison for kids. Despite our efforts and a growing national awareness about opiate and heroin addiction, opiate abuse continues. In Vermont, we’re going to keep fighting against these addictions. We have to. And we’ll have to fight even harder as long as the FDA keeps making incredibly misguided decisions about approving highly addictive painkillers.

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