Why the FDA is wrong on Vicodin
By Judy Foreman
The US Food and Drug Administration’s recent decision to restrict access to hydrocodone-containing drugs such as Vicodin may or not may not do anything to reduce the prescription drug abuse problem. But it will almost certainly hurt legitimate pain patients who need the drugs.
The federal government, and America’s public debate in general, has focused almost exclusively on the supposed “epidemic” of prescription pain-reliever abuse, not on the far larger problem of chronic pain in America.
But consider the numbers. In 2011, the prestigious Institute of Medicine issued a report showing that out of 238 million American adults, 100 million are living in chronic pain, and many, though certainly not all, are disabled by it. (This number is undoubtedly an underestimate because it does not count children, people in the military and people in nursing homes.) Chronic pain is, by some measures, the main reason people go to doctors and is a bigger problem than heart disease, cancer and diabetes combined. People with chronic pain are at roughly twice the normal risk of suicide.
By contrast, the prescription pain reliever abuse problem is much smaller. In 2010, according to the federal Centers for Disease Control and Prevention, 16,651 people died in opioid-related deaths. (“Opioid” is the term scientists now prefer, instead of “narcotic.”) Obviously, that’s 16,651 people too many. But those same government figures show that only 29 percent of these 16,651 deaths involved opioids alone—the rest involved alcohol, benzodiazepines or other drugs. Yet it’s opioids—like the legitimate pain patients who need them—that get vilified.
It’s estimated that 12 million people a year are abusing opioids. But the denominator in this equation is never mentioned, and it’s huge. In 2009, 200 millions prescriptions for opioids were filled nationwide, according to the SDI Vector One National database, a privately owned prescription and patient tracking services.
Moreover, the government continues to see prescription drug abuse as a law enforcement, not a public health, issue. Recently, for instance, in the wake of genuine and infamous problems with “pill mills” in Florida, the Drug Enforcement Administration cracked down on Walgreens, the largest pharmacy chain in the country, imposing an $80 million settlement.
Okay, that’s great. But Walgreens’ response has been to make it tougher for pain patients to get the drugs they need. Walgreens’ says its new policy “may, at times, require” pharmacists to contact prescribing physicians to make sure the diagnosis, the exact billing code, the expected length of therapy and the “previous medications/therapies tried and failed” are correct. Once again, whether this action will have a positive effect on the drug abuse problem is unclear. But it has already imposed extra hurdles for legitimate pain patients.
Put bluntly, we’ve got the shoe on the wrong foot. The common presumption—by the government and, unfortunately, by some physicians as well—is that every pain patient is likely to be a real or potential drug abuser. That’s simply not true. Many pain patients take opioids and other drugs for years, even decades, without abusing them.
For the record, I’m no fan of Big Pharma, or even opioids. Opioids are highly imperfect drugs with lots of side effects, not even counting the risks of dependence, hormonal and immune problems or the potential for abuse. Opioids can reduce pain, but they often fail to eliminate it. What they can do is allow some people to manage their pain enough to get on with their lives.
Bottom line? The FDA’s decision to make drugs like Vicodin less available punishes the wrong people. It may or may not make it harder for determined street abusers to get the drugs, but it will certainly make it unnecessarily hard for legitimate pain patients to do so.