Off Label Drugs and Free Speech

The Food and Drug Administration (FDA) has ruled that pharmaceutical companies cannot promote drugs for purposes other than the reasons for which the drug was approved. Physicians are free to do such off-label prescribing, however the drug companies cannot suggest in any way that physicians and other prescribers do so.

Companies have to do expensive studies to show that a medication is both safe and effective. How the FDA approves the drug is based on the research the company did. For example, Neurontin (gabapentin) is approved for certain kinds of seizures, post-herpetic neuralgia, and neuropathic pain. In 2004 Warner-Lambert paid $430 million in a court case brought by the government for off label use. The pharmaceutical company sales representatives had, promoted it for conditions including bipolar mental disorder, Amyotrophic Lateral Sclerosis, attention deficit disorder, migraine, and other conditions.

Some of those claims were true, and the company later received the nerve pain indications that it didn’t originally have. Physicians may rightly prescribe the medication without it having an indication because they have reasons to believe it may work based on the pharmacology or published studies. The pharmaceutical company may just not have been able to get it approved yet, or if it’s not a common problem, they may decide that financially it’s not worth the cost of getting an indication.

When a physician prescribes a medication, there is usually no direct economic benefit to them, and whether they are right or wrong, they will prescribe a medicine because they think it will benefit the patient. That’s not necessarily true of pharmaceutical companies, though. They have a direct economic incentive to sell as much of their product as possible, and their sales reps are often compensated on how many prescriptions the doctors they call on write. So although many of the reps are ethical, economic pressures are a strong incentive to get them to push for off label uses. Multi-million dollar settlements help hold those pressures in check.

Recently a three-judge panel of the Second Circuit Court of Appeals, in a case involving pharmaceutical sales rep Alfred Caronia, ruled that the FDA regulations violated the First Amendment’s guarantee of free speech. In an editorial the Wall Street Journal sided with the court, saying that, “health regulation is by nature health coercion.”

The Wall Street may smack down anything at all related to the Affordable Care Act (ObamaCare), but I think they are wrong. I’m not a lawyer, and much less a constitutional one, but I think of free speech in a different way. I don’t think selling a product is free speech. Selling an idea is. If you are not allowed to put up a sign touting you believe or don’t believe in God, for example, then your right to express your opinion is being abridged. If, however, you put up a sign saying the price of gasoline at your station, that’s not stating what you believe in, that’s just advertising. Granted, some cases might be fuzzy and I would err on the side of free speech, but sales reps talking about their medications are usually just advertizing. In fact the FDA does allow companies to support off label use, but it’s strictly limited (done by a physician in response to questions, etc.).

The Supreme Court acted in a similar manner in 2010 when they removed some limitations to political causes, allowing unlimited donations. This led to over a billion dollars donated in the last presidential cycle. It was done in the name of free speech, but because they could blanket the airwaves with ads, I’d argue those with less money basically lost some of their free speech to rich donors.

A lot of taxpayer money is spent on prescription medications. Busy physicians don’t have time to fact check every thing pharmaceutical sales reps tell them. Allowing reps to say whatever they want, in the name of free speech, is not good for anyone’s health, other than perhaps that of the pharmaceutical companies.

Aspirin – Coated or Naked – Does it Matter?

Aspirin is often used to prevent heart attacks and strokes. Patients usually take an 81 mg (baby aspirin) or 325 mg (regular strength) pill. It also comes in plain, enteric coated, or buffered. Enteric coated aspirin is often recommended to decrease the risk of ulcers, the idea being that it doesn’t dissolve until it gets past the stomach, though there is limited evidence that it really makes a difference.

Another concern over the past decade is that some patients may be resistant to aspirin, and perhaps needed to be on more expensive medications, such as Plavix (clopidogrel), which recently went generic, though is still pricier than aspirin.

Now a new study from the University of Pennsylvania, published in the magazine Circulation, questioned the idea of aspirin resistance, and said that some patients who did not respond to the coated aspirin did respond to plain aspirin. But that does not mean you should conclude that taking coated aspirin may put you at increased risk for a heart attack.

This study looked at 400 health volunteers and gave them a single 325 mg dose of aspirin, either plain or coated, and measured the chemical cyclooxygenase-1 to see if it worked. If they appeared “resistant” then they gave one week each of coated 81 mg aspirin and clopidogrel. Although 49% of the volunteers did not respond to the single aspirin, they all responded to the daily dosing.

So the bottom line is if you take a coated aspirin every day, you probably don’t need to be concerned about it not working. If you don’t regularly take aspirin, but experience chest pain, after you call 911, take a plain aspirin, and preferably chew it to speed absorption. If you only have coated aspirin, it should work just as well if you chew it. Coated aspirin, made by Bayer and other manufacturers, are a little more expensive than plain aspirin, but are still fairly inexpensive.

Dangers of a Transparent Medical Record

Over the years there has been a push to allow more patient access to their records. Patients in our system that have signed up for MyChart with our electronic medical record Epic, can see most of their test results shortly after they are back, even if not yet reviewed by the physician who ordered them.

To avoid patients misinterpreting or reacting badly to the results, certain tests, such as HIV and pathology, are not automatically released. Although releasing the results automatically acts as a safeguard for abnormal results that may have been missed by the physician, it also opens the possibility of patients inappropriately acting on the results.

I’ve had patients make changes in their medications after seeing their results, and without even discussing it with me until their next visit. One patient who saw that his sleep study showed he had sleep apnea, borrowed a friends extra CPAP machine, adjusted the settings based on his research on the internet, then tried it out for 2 weeks!

As the saying goes, a little knowledge can be dangerous. Patients should use the information in their charts to inform them, and help ask educated questions, but not to replace their physician. There is often a lot more to making a diagnosis and deciding on a treatment than just looking at test results.

Over-the-Counter Confusion

Over-the-(sushi)-counterThe FDA allows some medications to be sold over-the-counter (OTC), generally after patent expiration. Pharmaceutical companies need to prove they are safe to be taken that way. But as more medications become available, the opportunities for confusion increase. I’ve had patients confuse Zantac and Zyrtec. The first is for acid reflux and the second is for allergies. Even if drugs have similar names, a pharmacist usually catches the difference due to the dose written on the prescription. For example, Zantac comes in 75 mg, 150 mg and 300 mg, but Zyrtec is 10 mg. The typical lay person doesn’t know what dosages medications are supposed to be. They just (hopefully) know how many pills to take. So if they don’t read the label, they may take the wrong medication due to getting the names confused.

Anti-inflammatory pain medications are particularly a problem. There are OTC versions (Advil, Motrin, Aleve, etc.) and prescription dose strength versions of those, as well others that do not have a generic version. This class of medications is called non-steroid anti-inflammatory drugs (NSAIDS), and usually people should not take more than one at a time. But not uncommonly I see patients take a prescription one plus an OTC one, not realizing they are similar medications. By doing this you get very little additional benefit, but more risk of side effects.

If you use OTC products, be careful to read the labels carefully. If you are taking prescription medications for the same purpose, or you have any of the conditions they warn you about on the label, check with your physician first.

Making the Affordable Care Act Individual Mandate Work

The Supreme Court has ruled that most of the Affordable Care Act, aka Obamacare, is constitutional.

In order to provide affordable care to all, insurance companies need the healthy to pay premiums, and not just the people who will use a lot of health care resources. In order to try and ensure this, Congress gave a penalty for those who don’t purchase an insurance plan. The problem is that the penalty is far less than the cost of insurance, and the only way they can even force you to pay is if you are getting a tax refund, in which case they can deduct the fine. So someone could elect to go without insurance, and, whether or not they pay the fine, just sign up if they need it. If enough people did that, the plan would not be sustainable. The penalty is $695, and up to $2085/year or 2.5% of income for a family, though it’s lower the first two years. A healthy individual might decide $695/year for no insurance is a better deal than $2000/year for insurance they don’t think they need.

So I propose a solution. Congress could pass a law saying that if someone does not get and maintain insurance within 1 year of when it becomes mandatory, and if they elect to get it later, they will be responsible for the first $10,000 or so expenses they sustain within the next 3 months of applying for insurance. If they get in a major accident or discover a lump that turns out to be cancer, they will still be able to get care and not be burdened with medical expenses that could easily far exceed $10,000. But for those considering going without insurance, even that would be a tough bill to pay.

Of course even now people go without insurance because they feel they can’t afford it. Although that could still apply after the Affordable Care Act goes into effect, the calculations change. Just as a poker player will adjust their bet depending on the size of the pot, I believe consumers would do the same. Instead of a cost of $2000/year versus $0, it would be $2000 versus $695, for example. Thus the cost of going without insurance in this example would drop from $2000 down to $1305 after paying the penalty (or tax, depending on your point of view). Balancing the benefits of having insurance and the risks of not having it, I think more people would elect to get insured with this plan.

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.

Exam Room Miscommunication

In school were you ever challenged to explain to someone how to make a peanut butter and jelly sandwich using words only? It’s harder than it sounds. Similarly it’s sometimes difficult to explain to a patient what I want them to do, at times to humorous effect. If you see yourself in any of the examples below, don’t take offense. I’m laughing with you, not at you!

As I bring an exam light up to check patient’s eyes, they often open their mouth, thinking I want to check their throat.

When checking guys for hernias I tell them to turn their head and cough. Men often turn their head to the left when I check their right side, then turn to the right when I check the left. The only purpose of having them turn their head is to not cough on me! Before doing this part of the exam I tell them to drop their drawers so I can check them for a hernia. I like to then slide forward the 2-3 feet on my stool, that has rollers, but guys often take a step towards me first, then I have to make sure I don’t butt heads when they naturally bend to drop their underwear. I also like to go to their right side so I don’t have to bend my wrist back, but in an attempt to be helpful, they often turn to the right to face me, so I have to slide farther to the side, thus doing a hernia check dance.

When I have people sit up on the exam table, they often start to lay down. I just want them to sit first since I like to examine their neck and listen to their lungs first. If not doing a full physical, I usually just pull up the shirt to listen to their lungs from the back side. When I then have them lay down, patients usually reflexively pull their shirt back down, but then I have to lift it back up to listen to their heart.

When patients have pain, such as in their abdomen, I’ll ask them to tell me if it hurts as I press in various areas. In an attempt to be helpful, patients off start pushing on their stomach themselves to try to find the tender areas, and sometimes will spend a fair amount of time doing so. I usually joke that they can examine themselves on their own time, but now it’s my turn.

Rush to Judgement

Conservative radio show host Rush Limbaugh recently launched an attack on Georgetown University law student Sandra Fluke. She had testified to house Democrats in support of mandates to provide contraceptive care in insurance plans. On his show two days later, Rush Limbaugh said that Ms. Fluke  was asking for taxpayers to pay her to have sex, and that made her a, “prostitute”.

Others have chimed in that contraception is a lifestyle choice and society shouldn’t have to pay for it.  Whether or not you believe women have the right to get an abortion, it’s a flawed argument. By the same reasoning, insurance shouldn’t cover heart attacks, strokes or cancer if the person smoked or was obese. It’s one thing to incentive healthy behavior, but Rush Limbaugh’s attack is either not well thought out in regards to its health care implications, it’s misogynistic, or it’s politically motivated.

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