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.

Drug Shortages and the Joint Commission Stance

Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.

Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.

I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.

So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.

Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.

Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.

Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.

A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.

The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.

I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.

Practicing Medicine Without a License

Not infrequently, patients question me about a medication because they’ve heard it’s unsafe. Often it’s from lawyers advertising the dangers of a particular medication or medical product. Although on occasion this may be a good service, most of the time it’s not.

All medications have both benefits and risks, and just because there is a potential problem, doesn’t mean it’s not worth the risk, and it doesn’t mean that alternatives are any safer.

Lately I’ve had patient’s refuse to take Actos for fear of bladder cancer. I don’t see lawyers advertizing about sulfonylureas, probably because they are generic, but they are more likely to cause hypoglycemia, which is much more common than bladder cancer, and may be more serious.

Maybe we need lawyers to go after the lawyers. “Did you suffer any problems after stopping a medicine because you read that it’s dangerous?” Sure, they’ll claim first amendment rights, but maybe they could charge them with practicing medicine without a license.

Viewing Doctor’s Notes

Should patients be allowed to see doctor’s notes? Legally they can, but that doesn’t necessarily mean it’s a good idea. Patients would like to, but physicians are not so sure. People make strong arguments, but I think it’s really nuanced.

Physicians often write down the differential diagnoses. Say you’ve lost a little weight without trying. It could be a lot of things such as stress, cancer, an overactive thyroid, an ulcer, HIV AIDS, tuberculosis or a thousand other things. After asking a number of questions and doing an exam, I may decide that it’s unlikely that there’s any serious medical problem going on and prescribe a medication for depression. When I see you back in a month I’ll order additional tests if you have not responded as expected, and particularly if you’re still losing weight. But in my first note, I would have likely at least mentioned some of the diagnostic possibilities, and probably using medical terminology such as malignancy. I write these for a number of reasons. Mostly it makes for good care. Just in case it turns out to not be depression, when I look back at my prior note it will remind me of some of the concerns I had. It also provides a road map of what I was thinking if the patient has to see another physician, whether it’s because I’m on vacation, they have to go to the emergency room or see another physician. The note is also necessary due to malpractice concerns. Doctors are usually not expected to know the future, but the legal assumption is that if you didn’t write it down, it didn’t happen. If you don’t show that you considered the possibility of a serious condition, the presumption is it didn’t cross your mind.

Psychiatrists are allowed to protect their notes. Is that because their patients are too unstable to see their notes? Is it because the psychiatrist needs to record things that a patient may misinterpret? During the course of treatment they might have some insight about a patient’s problems, but not know whether their guess is right. By recording their thoughts they can later go back and review them, improve their diagnosis and treatment, and better help the patient. Well the majority of psychiatric care in the United States is actually provided by primary care physicians. There are not enough psychiatrists to treat all the cases of depression and anxiety. But primary care physicians notes are not similarly protected.

One measure of the benefit of a treatment is the number needed to treat. For example, one may need to treat 20 patients with a cholesterol medication for a year for every heart attack prevented. Conversely is the number needed to harm. Depending on age, it’s estimated that for about every 1500 abdominal CT scans, one person will get cancer as a result of the radiation. A good clinician will be correct the majority of time. How many patients will be harmed by reading chart notes (needless worry, additional tests that have their own risks and costs ordered because of that fear, physicians not recording important information for fear of it being read by a patient) for every patient that benefits?

I’m not embarrassed by what I write in a patient’s chart, but patients might be if they read it. Imagine a man asks a family member to review his medical records to see if they think he has been getting good care, given his recent heart attack. He probably forgot that a few years ago he spoke with me about sexual problems he was having.

The system I suggest would be a juried one. Patients could request their records, and in most cases the physicians would grant access to most or all of the record. If there was parts they did not want to show, they could explain why to the patient. If the patient did not accept the answer, they could appeal to a third party health advocate who would then decide whether it should be released or not. This would only apply to patients who are not bringing legal action. I think this approach would make physicians a little more comfortable, and lead to better patient care.