Tag: FDA

Quitting Smoking and Happiness

The FDA is proposing a new rule in regards to tobacco regulation. As detailed recently in the New York Times, the benefits of stopping smoking, such as less heart and lung disease, would need to be discounted 70%, making it that much harder to justify spending money on smoking cessation. It sounds like something inserted at the bequest of tobacco lobbyists. Tomorrow is the deadline to make a public comment. Here is what I submitted:

I think it’s a dire mistake to discount the economic and health benefits of stopping smoking because of the loss of enjoyment. Although smokers may get temporary enjoyment from smoking, they also get enjoyment from being healthy. Surely one gets more pleasure taking a walk in a park and living at home, than pushing an oxygen tank down a hall in a nursing home because of severe emphysema. Smokers die at a younger age than they otherwise would. What about the enjoyment their partners, children, and grandchildren lose when the smoker dies prematurely? Loss of enjoyment should not be part of the equation, unless it’s a negative number which would serve to magnify the cost smoking places on individuals and society.

Medication Small Print

WhenSolu-Medrol_crop I give a cortisone injection, I have to document it in our electronic medical records. I’ve always included the dose, how administered (intramuscular), and the lot number. This week my company added the requirement that we include the NDC number, as insurance companies wanted the information.

It’s just one more administrative requirement, but what really makes it bad is trying to read the number off the bottle. As you can see from the photo, the font is very small! I suggested the policy was age discrimination, but that didn’t get far.

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.

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.

Ask the Doc: Human Growth Hormone

On this site I’m unable to answer patient specific questions, but as time permits, may answer questions of a general interest.

Question:

I have been working out with a personal trainer with weight training and have been doing running on my own. I have been getting much stronger although I haven’t lost much weight. I asked the trainer why it takes longer to recover from a strenuous session at age 66 than it did when I was younger. She said that as we get older we have very little HGH in our system and that a small dose of HGH would help me recover quicker and she could push me harder. Would a small dose of HGH be beneficial for training? I know that testosterone creams etc. have a lot of side effects which are not good but how about HGH?

Answer:

Human Growth Hormone, or HGH, is a hormone that regulates growth, and decreases with age, as well as from obesity. It is one of many factors why, all other things equal,  66-year-olds aren’t as strong or fast, or recover as quickly, as when they were younger. With age lung function gradually declines, the cardiovascular system is less robust, testosterone levels fall in men, etc. In one of his movies, Warren Miller said something like, “If a 40-year-old says they sky as well as when they were 20, they are either lying, or they weren’t very good when they were 20!”

Human Growth Hormone is only approved by the FDA in limited circumstances, not including the normal decline with aging, and it’s expensive. It probably does build muscle, and for this reason is banned by the Olympics and some other sports institutions. It also has potential side effects.

Getting adequate sleep, regular exercise, eating healthy, and managing stress, are the most important things you can do to boost your growth hormone and improve your endurance.

Over-the-Counter Lipitor?

According to sources in the Wall Street Journal this week, Pfizer said they would apply to sell Lipitor over the counter. This is a bad, bad idea. Lipitor is in the class of medications commonly called statins. Although it’s an excellent drug, it can have serious side effects, including liver and muscle damage. Presumably an OTC dose would be low, and less likely to cause side effects, but it’s still likely patients would inadvertently take it in addition to statins prescribed by their doctor, or along with red yeast rice, a naturally occurring statin.

Even if there was zero risk of side effects, there is a high risk that patients would not use the medication properly. Lipid (cholesterol, triglycerides (fats), HDL (good cholesterol), LDL (bad cholesterol), etc.) management can be quite complex. One should know medical problems that might exacerbate the problem, such as diabetes and thyroid problems. There are many medications to choose besides statins, and different ones work better for some people than others. Then you have to know how aggressively to treat, which depends on the risk of cardiovascular disease, among other things.

Over-the-counter Lipitor would certainly be cheaper than the current prices, but it would likely be more than the generic price. Even if priced below generics, it could cost consumers more because their insurance would likely not cover it if it was available over-the-counter. This is what happened with the antihistamines Allegra and Zyrtec, though generic Claritin (loratadine) is quite cheap now.

So given all the down sides, why would Pfizer try to get OTC Lipitor approved? I wonder if it could have anything to do with their loss of patent protection when it goes generic 11/30/11?! Fortunately it’s unlikely the FDA will fall for this.

%d bloggers like this: