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FDA urges drug companies to make a safer pain killer

The prescription medicine OxyContin is displayed at a Walgreens drugstore in Brookline, MA.

The Food and Drug Administration has a prescription painkiller epidemic on its hands. More than 16,000 people died in 2010 from overdosing on painkillers like OxyContin and Opana.

That’s why the FDA is considering a proposal to restrict access to the drugs making it harder to get a prescription.

But that’s just part of the plan to tackle the problem. The agency is playing a bigger role in the $8.5 billion dollar painkiller market, challenging the drug industry to build a painkiller that’s harder to abuse.

“The federal government is going to be a player as never before in this market,” says Dan Carpenter, professor at Harvard University and author of the book "Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA."

Historically, Carpenter says that once the agency approved drugs, it didn’t mettle after with them again. But, it’s different with painkillers.   

“The federal government is actively shaping the way in which the drug is consumed.”

The FDA wants new drug formulations that make it very hard to get high, like pain pills you can’t crush into a powder to shoot or snort, as well as more rigorous, independent testing.   

The FDA is wading into the marketplace because addiction to painkillers, both prescribed and taken illegally, is soaring.  

IHS analyst Gustav Ando says the FDA is dangling a sweet carrot. “The rewards here are pretty big,” says Ando

If a drug maker comes up with a tamper-proof drug, the FDA will label it "proven to reduce abuse," which could lead to more prescriptions -- or as Ando says, gold.

“Pharmaceutical companies really go where the money is," he explains. "Providing the next generation painkiller -- you can’t ask for much more than that.”

Right now, the painkiller market is dominated by generics. A new safer pill would let Big Pharma grab a chunk of that back.

“This is one of these ironic circumstances, in which…the big line companies will actually do better, even though they are being heavily regulated,” says Harvard’s Dan Carpenter.

Philadelphia doctor Aviva Fohrer treats opioid addicts. She likes the idea of a safer painkiller, but there are tradeoffs.

“They’ll get a cheaper, easier drug, which is generally heroin. And the ramifications of that are it’s not produced by a pharmaceutical company. You don’t know what the doses are, you don’t know what’s in it,” Fohrer says.

Fohrer points out the new generation of pills -- if developed -- are still dangerously addictive. That’s why the doctor says the solution has to be more than yet another pill, albeit one that’s harder to abuse.

About the author

Dan Gorenstein is the senior reporter for Marketplace’s Health Desk. You can follow him on Twitter @dmgorenstein.
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There is another solution. A solution that can work in tandem with other FDA, pharma, and legislative efforts already in the works. Opioid overdose kills by depressing respiration (making the victim stop breathing). Naloxone is an opioid antagonist that reverses the effects of opioid overdose. It is used routinely in clinical and pre-clinical care, by paramedics, ER physicians, anesthesiologists, and other medical providers to reverse the effects of opioids and restore breathing to an overdose victim. It has no potential for abuse and has no effects if the patient is not using opioids.

Since 1996, programs in the US and elsewhere have trained people at risk for opioid overdose to use naloxone and reverse potentially fatal overdoses. A recent CDC report showed that there are over 150 of these programs in the US, run by state/local health departments and community based programs. These programs have recorded upwards of 10,000 overdose reversals (i.e., "lives saved").

Currently, naloxone is available in the US only with a prescription. Physicians prescribing opioids to their patients can also prescribe naloxone, which could be used to save their lives if they overdose on the drugs they are prescribed. Addiction medicine physicians who know that their patients are at risk for overdose from legal or illegal opioids can also prescribe naloxone that could be used to save their lives if they overdose.

Facilitating increased access to naloxone by making it available over the counter could dramatically increase access to this life saving drug.

Responding to the epidemic of drug overdose in this country will take a multifaceted approach. Increased access to naloxone should be one of the solutions.

It is sad and amusing how little we learn from history. A new generation of pills? This has been done before. Many times. Heroin was originally a brand name. It was an opiod produced by Bayer to replace Morphine, and was marketed as being safe and not addictive. Years later, Methadone was developed to cure heroin addicts. Lo and behold, it was equally addictive, with a much longer half-life, making it harder for addicts to withdraw from the drug that they were taking to withdraw from another drug. Ludicrous.
Drugs like Oxycontin, Dilaudid, Fentanyl, Percocet, Vicodin, etc. are drugs that really don't do anything that good old-fashioned Morphine can't do (with very specific in-patient or surgical exceptions.) They are primarily money-makers for drug companies, that's it. It's not just narcotics where this happens, also. Valium is too habit forming, try Ativan! Prozac have too many side effects? Try Zoloft! Giving patients the same type of thing under a different name has a long precedent in our society. You can already see the writing on the wall in this story. There will be a new influx of "non-addictive drugs", lauded by the FDA as the answer all of our problems, just like Heroin and Methadone and Oxycontin before them. Then, just like those drugs, it will turn out that they can in fact be abused, and if history is any guide, the abuse will be more insidious and harder to untangle than it is now.
As long as people feel the need to anesthetize themselves, they will find a way. In moderation it may not even be a bad thing. Certainly alcohol is used for this purpose. Addressing the growing compulsion to abuse (drugs, alcohol, sex food, etc.) within our society seems like a better use of our taxpayer dollars than simply throwing new drugs at the problem. To simply leave it at that is to rearrange deck chairs on a sinking ship. Futile.

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