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The FDA dithers as prescription painkillers claim more lives

Nothing about Sarah Bowker says “drug addict.” She’s a 37-year-old homemaker who dotes on her 4-year-old daughter and has never had a brush with the law.
Prescription pills containing oxycodone and acetaminophen are shown in this June 20, 2012 photo. (Photo by Graeme Roy/The Canadian Press/AP)
Prescription pills containing oxycodone and acetaminophen are shown in this June 20, 2012 photo.

Nothing about Sarah Bowker says “drug addict.” She’s a 37-year-old homemaker who dotes on her 4-year-old daughter and has never had a brush with the law. Yet it wouldn’t be a stretch to call her the new face of addiction in America. Bowker developed rheumatoid arthritis in 2008, and it flared up badly after she gave birth that year. Her rheumatologist dashed off a prescription for a generic form of Vicodin, the popular pain killer that combines acetaminophen (as in Tylenol) with a narcotic called hydrocodone. The pills brought welcome relief for a few weeks but soon lost their punch, so the rheumatologist referred her to a pain specialist.

That’s when the real trouble began. In keeping with widespread medical practice, the specialist gave her a formulation that contained more narcotic. But the pain returned as Bowker’s body adjusted, and an arms race ensued. Over a two-year period, she combined ever-larger doses of hydrocodone with other opioid drugs such as oxycodone and morphine sulfate. Though prescribed as approved by the Food and Drug Administration, the drugs took over her life. “I couldn’t finish a sentence,” she recalled in a letter to the FDA late last year. “I was losing my memory. I had become severely depressed. I convinced myself that my husband and 2-year-old daughter were better off without the burden of my being.”

More deaths than cocaine and heroin combined

Bowker survived by tossing her medications and weathering 10 days of physical withdrawal—complete with tremors, vomiting, night sweats and hallucinations. But people hooked on narcotic pain killers don’t always fare so well. Every year, these blockbuster pharmaceuticals cause more deaths than cocaine and heroin combined—and the toll is rising fast. The government’s latest figures show that opioid pain relievers killed 16,600 Americans (10,000 men and 6,600 women) in 2010 alone. That number represents a fourfold increase over 10 years, and many of the victims are people just like Bowker.

The Centers for Disease Control and Prevention issued its latest alarm call this month, declaring that “stopping this epidemic is everyone’s business” and urging doctors and patients to take greater precautions with narcotic painkillers. That’s critical, of course, but the epidemic hasn’t occurred in a vacuum. Experts, advocates and public agencies have spent years urging the FDA to regulate these drugs more carefully. The proposals aren’t draconian—narrow the indications for treatment, specify maximum doses and durations, apply the same restrictions to all opioid medications—but the manufacturers and their surrogates have fiercely resisted these measures. And for 14 years, the FDA has sided with them.

Agency officials wouldn’t put it that way, of course. By their account, they’re just being careful not to overregulate products that millions of pain sufferers depend on. “These are not simple issues and there are no easy answers,” FDA Deputy Director Douglas Throckmorton told a congressional subcommittee last month. “Given the complexity of the issues surrounding the abuse, misuse, and addiction to prescription painkillers, real and enduring progress will require a multi-faceted approach combined with the dedication, persistence, and full engagement of all parties.”

Throckmorton claims the FDA has employed a comprehensive “science-based” strategy to address every facet of the problem over the past decade. Specifically, he says the agency has promoted public awareness of the drugs’ hazards, encouraged companies to make pills that can’t be crushed for illicit use, “improved the availability” of drugs that can counteract an overdose, and “evaluated” possible changes in labeling. But while the agency has pursued this course, the drugs’ sales have doubled—from $4 billion $8.3 billion, according to a New York Times analysis—and the epidemic of addiction and overdose has spun out of control. Death toll aside, opioid painkillers now cause 900,000 emergency hospital visits each year—a threefold increase since 2004—and doctors write 8 million prescriptions for drugs to help treat people’s addictions.

Drug sales continue to surge

The surge in sales is no accident; pharmaceutical companies have worked aggressively to rebrand drugs once reserved for end-stage cancer patients as general remedies for chronic pain. As early as 2003, the General Accounting Office reported that Purdue Pharma had mobilized “an expanded sales force to encourage physicians . . . to prescribe OxyContin not only for cancer pain but also as an initial opioid treatment for moderate-to-severe non-cancer pain.” Physicians got trips, toys and speaking fees. Patients got “starter coupons” redeemable for seven to 30 days’ worth of free medication. Sales soared, and the Drug Enforcement Administration worried publicly that non-specialists were prescribing the drug too freely.

In 2007, the FDA’s Office of Criminal Investigations busted Purdue for intentionally misleading physicians about OxyContin’s hazards, and the company paid more than $600 million in civil and criminal fines. But most of the opioid marketing ploys were perfectly legal under the broad approvals FDA had granted during the 1990s. Though the painkillers were tested only for short periods in seriously ill patients, the agency cleared them as treatments for any “moderate to severe” chronic pain. “We now have overwhelming evidence that long-term use is unsafe and ineffective,” says Dr. Andrew Kolodny, the New York City psychiatrist who heads Physicians for Responsible Opioid Prescribing (PROP). “But the approval language lets manufacturers promote long-term use, and it lets physicians think they’re prescribing the drugs appropriately when they’re not.”

Last year, PROP and other health groups proposed three reforms to correct this oversight. In a formal petition, they asked the FDA to (1) strike the term “moderate” from the indications for non-cancer pain, (2) add a maximum daily dose, equivalent to 100 mg of morphine, for non-cancer pain, and (3) add a maximum duration of 90 days for daily treatment of non-cancer pain. “The Food, Drug and Cosmetic Act established that a drug intended to treat a condition must be proven safe and effective for use as labeled,” the advocates note in their plea. “The current label on opioid analgesics does not comply with this law.”

In keeping with its protocols, the FDA held a hearing and collected public comments on the proposal. But a full year later, the agency has nothing to say about the issue. “You are correct that the FDA has pending citizen petitions regarding opioid labeling,” spokeswoman Morgan Liscinsky said in a written statement, “but we cannot comment on pending petitions other than to say our analysis and decision-making processes are ongoing.”

Convenience over safety  

The agency has been even slower to deal with another key reform effort. Federal law uses five categories to denote different drugs’ potential for abuse; Schedule I compounds are the most tightly restricted, Schedule V the least. With FDA’s blessing, the Drug Enforcement Administration lists most narcotic painkillers as Schedule II, a designation that tightens prescription procedures and helps regulators track them more closely. But products made with hydrocodone—the drug that started Bowker down the path to addiction—have all been grandfathered into Schedule III. The distinction may sound trivial, but many experts believe the designation has fueled the over-prescription of Vicodin by letting doctors phone in prescriptions on request—a convenience that manufacturers tout in their advertising.

Physicians, health authorities and law enforcement officials have spent 14 years asking the FDA to fix this inconsistency. Dr. Robert Dupont, the first director of the National Institute for Drug Abuse, says reclassifying hydrocodone is “one of the single most important interventions the federal government could implement to bring this raging epidemic under control.” The DEA itself sought the FDA’s consent in 2004 and again in 2009, only to be rebuffed.  Finally this year, FDA agreed to hold a hearing on the issue and let an advisory panel weigh the arguments. Skeptics claimed the change would inconvenience patients and pharmacists without quelling abuse, but the expert advisors voted by a two-to-one margin to regulate all opioids consistently.

Health advocates rejoiced, assuming the agency would quickly follow the panel’s advice. But six months later, the agency has yet to act. When a bipartisan group of senators asked the FDA’s Commissioner, Dr. Margaret Hamburg, how much longer the country would have to wait, she declined to offer a timeline. “Not only is 14 years more than enough time,” the Senators wrote in a second request dated May 9, “but this rescheduling process has exceeded the . . . requirement of the Controlled Substances Act. The American people have waited too long for action from this agency.”

Why the continued foot-dragging? When asked by msnbc, the FDA’s press office merely restated the obvious: “Rescheduling hydrocodone combination products from schedule III to schedule II is a complex scientific, medical and legal issue . . . . The agency is in the process of reviewing over 500 comments from the public. . . . The recommendations we are receiving are not at all unanimous. . . . Some health professional groups do not favor rescheduling because they are concerned this change would restrict access to patients who most need these medications.”

FDA officials may genuinely believe they must balance the wishes of all parties. But that’s not the agency’s mandate. As Kolodny puts it, “the law doesn’t give them that discretion. They’re supposed to act on the basis of safety criteria.”  It may yet fall to Congress or the courts to rein in the marketing of narcotic painkillers. Until then, the market is sure to expand. And so is the suffering it causes.