Super-Duper Hydrocodone? An Open Letter to Big Pharma

A powerful and addictive new painkiller is coming down the pike. Can this be anything but an unmitigated disaster?

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Dear Giant Multinational Pharmaceutical Companies:

First, a little love. In a lot of ways, you guys are just the best. Your products cure infections, prevent diseases, control blood pressure, lower cholesterol, lift moods, bust clots, manage chronic diseases and treat thousands of often obscure ills with thousands of ingenious preparations. In a world in which it would be a lot easier to manufacture cigarettes or handguns or pork rinds, you produce medicine. So thanks.

All that said, recent reports also make it fair to ask: Are you nuts? Just this week, the Associated Press revealed that four of you Big Pharma boys — and I’m looking principally at you, San Diego-based Zogenix — are hoping to release a super-duper, high-octane form of the opioid painkiller hydrocodone, containing up to 10 times the dosage of the drug currently available in the already crazily addictive drug Vicodin, and that the Zogenix pills could be on the market as soon as 2013 with others to follow.

Let’s take a moment to review the numbers. As the Centers for Disease Control and Prevention reported in November:

  • Enough prescription painkillers were prescribed in 2010 to medicate every American adult around-the-clock for a month.
  • Prescription painkiller overdoses killed nearly 15,000 people in the U.S. in 2008. This is more than 3 times the 4,000 people killed by these drugs in 1999.
  • In 2010, about 12 million Americans (age 12 or older) reported nonmedical use of prescription painkillers in the past year.
  • Nearly half a million emergency department visits in 2009 were due to people misusing or abusing prescription painkillers.

What’s more, in 30 states, unintentional overdoses have surpassed motor vehicle accidents as the leading cause of unintended death. Want more? As TIME reported last year, in 2010, seven people died every day from prescription drug overdoses in Florida alone — the state that has long been the nation’s capital for quasi-legal pill mills, essentially drug trafficking centers thinly disguised as pain clinics.

LIST: The Painkiller Overdose Epidemic, and 7 Other Stories to Watch in 2012

The pills responsible for all the suffering are overwhelmingly the hydrocodone-based drugs — OxyContin, a time-released formulation of the pain-killing opioid; Oxycodone, the same drug without the same safeguard; and hydrocodone (sold under numerous names, including Vicodin), that includes acetaminophen in the mix.

Granted, most people who become addicted are not legitimate pain patients; rather, they’re recreational users who get the drugs from family and friends. But many addicts do get their medication lawfully, from a doctor. They’re folks who undergo routine tooth extractions or other ambulatory procedures and are given a 30-day prescription for painkillers — a supply that, according to Cathy Barber of the Harvard School of Public Health, becomes a “little opioid starter kit.” Even when people don’t get hooked (and, admittedly, that’s most of the time), the unused drugs often sit in a medicine chest, where teenagers — the demographic ground zero for drug abuse — can get hold of them. Oh, and simply flushing the unused drugs creates problems of its own, since that contributes to a growing problem of pharmaceuticals in reservoirs and waterways.

So what exactly are you folks thinking? Well, it’s true, as your spokespeople say, that there are a lot of people out there who have chronic pain that is hard to manage with existing meds. But that’s been the argument for all of the opioids released up till now. What’s more, Zogenix, your own website says that your new product, [Zohydro], is intended for “moderate to severe chronic pain,” and while the severe end of that spectrum sounds nasty indeed, the moderate end might not require quite such a blunderbuss drug.

It’s true too that the new überhydrocodone will require patients to appear at a doctor’s office in person each time they want a prescription refilled — as opposed to simply getting a single prescription with five refills built in, as is sometimes the case with current hydrocodone-based meds. But you’re talking about 30 days of hydrocodone pills formulated at 10 times the current dosage. That — and feel free to check my math here — is the milligram equivalent of 300 days of the stuff. Might this be a problem? (In fairness, not every formulation of Zohydro would pack such a wallop. It’s only the highest-dosage 50-mg pills, compared to the lowest-dose 5-mg Vicodin pills, that cross the tenfold threshold. Still, the drugs will be out there and they’ll be catnip for addicts.)

Even if the once-a-month physician check-in is implemented and enforced, there are still plenty of ways to sidestep the rules — ways that addicts have long since perfected — including doctor-shopping and pharmacy hopping, the better to get multiple streams of drugs coming in from multiple sources unknown to one another. There are also black markets and unscrupulous docs who write ‘scripts on demand.

MORE: Viewpoint: Why Dr. Feelgood Isn’t Always Wrong

The states and Feds are doing what they can to turn off the opioid spigot. As TIME also reported, the U.S. Drug Enforcement Administration scheduled a national drug take-back day in Sept. 2010, setting up 3,400 collection sites around the country where people could safely dispose of unwanted or unused opioids. It helped — a little, but not nearly enough. Much more effective has been the crackdown in Florida on pill mills. By August of 2011, about 400 of the thousand pill mills in the state had been shuttered, with more being targeted. Just to drive the party’s-over lesson home, Florida prosecutors have also charged two doctors with murder after their pain clinic was linked to 56 overdose deaths. As the New York Times reported:

Charging a doctor and a clinic owner with homicide “was a game changer,” said Sheriff Ric L. Bradshaw of Palm Beach County. “You are not going to get a slap on the wrist. You are looking at life in prison.”

If you Big Pharma types are going to be really, truly, staring-at-the-ceiling-at-3-AM honest, you have to admit that at least part of your thinking is influenced by one other, very big number. Opioids represent a $10 billion per year market — a market that’s completely legal, completely open and completely justifiable (if you choose to think that way) by the people who do have severe pain and do need the relief. But putting a drug on the market before ironclad safeguards are in place to lock it up and dole it out one pill at a time to just the people who can’t live without it is irresponsible in the extreme. And one explanation for the new formulation — that the super pill will actually be safer since it eliminates the acetaminophen, which can be toxic to the liver — is risible. Liver damage is real, but it isn’t Tylenol poisoning that just bumped car crashes off the top of the accidental-death list.

MORE: Report: Chronic, Undertreated Pain Affects 116 Million Americans

As MBA professors endlessly tell their students, companies do best when they stick to what they do well. There’s a reason Apple doesn’t make blenders. There’s a reason Häagen-Dazs doesn’t sell meat. And there’s a reason drug companies should focus on saving and improving lives — not jeopardizing them. Just a thought as you make your resolutions for 2012.

Happy New Year

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