FDA and Generic OxyContin

As recently reported in the Wall Street Journal, the pain killer OxyContin is set to go generic next year, and Purdue Pharma is trying to postpone it.

A funny thing often happens before a drug goes generic. Close to that time the manufacturer comes up with a new indication, formulation or dose. They claim it’s an improvement in the product, but it often has the appearance of coincidentally coming out close to when they would lose exclusive rights to sell the product. And wonder of wonders, they often get the market to themselves for a longer period of time because of it.

As someone who treats a lot of patients with pain, from my perspective OxyContin is a fairly good drug. Because it’s timed release oxycodone, it often gives better pain control, has a lot of dosing flexibility, and probably has less potential of causing addiction than immediate release oxycodone. Less is not none, however, and it’s still a frequently abused drug, whether swallowing the pills, or more illicitly, snorting or injecting it.

OxyContin has a new formulation containing polyethylene oxide that makes it harder to crush or inject. Although it’s not yet clear how effective it will be, the street price has decreased, suggesting it is a less desirable drug for someone wanting to get high. So Purdue Pharma is arguing that no one should be allowed to sell timed release oxycodone that does not have the protection they have, which of course is itself patented until 2025. Purdue Pharma is being sued for allegedly previoulsy making false claims to doctors, minimizing the risk of addiction. That has bearing on their new claim that it’s the new and improved version that has the low risk.

Besides that the improved safety is still not certain, their logic is false. From the perspective of controlling drug abuse, supply will meet demand. People will find better ways to process the new OxyContin pills to make them easier to abuse, or they will use substitutes.

From the perspective of a clinician treating pain patients, the cost of the pills and insurance formularies often dictate what doctors can prescribe. I often don’t prescribe OxyContin now, even when I want to, because of this, and have to prescribe controlled release morphine (which used to be sold as the brand MS Contin), methadone, which is a tricky drug to prescribe with a higher risk of accidental overdose, or use other alternatives.

I hope the FDA does not accept Purdue Pharma’s argument. They should either allow generic OxyContin, with or without the polyethylene oxide contained in the new pills, or allow generic manufacturers to use other similar methods of deterrence.

Do Missing Child Posters Work?

On 6/7/12 The Today Show ran a story about missing children. They ran an experiment to see what people would do if they saw posters of a missing child, then actually saw the child. Working in conjunction with police and hidden cameras, they used a child actor, accompanied by a man acting brusquely. A number of people showed concern after seeing the poster then the child, but most people did not call the police. Their conclusion was that we need to pay more attention. But I think they drew the wrong conclusion. We are bombarded everyday with all kinds of visual information. Paying attention does not always suffice, as evidenced by this video.

I think a better conclusion to their study was that we need to find better ways to encourage people to act. People may not call because they are afraid they may be wrong, they fear getting involve, or for other reasons. I’d suggest doing some psychology experiments with posters displaying different messages: 1)If you see this girl, call 911, 2)If you think you saw this girl, but you’re not sure, call 911, 3)Imagine this was your daughter, what would you want people to do if they thought they recognized her?, etc.

It’s heart wrenching to see missing children posters. Perhaps a better understanding of what keeps people from following through when they identify one, will help save more.