Have you ever stood in front of a drugstore shelf with a splitting headache, Advil in one hand, store-brand ibuprofen in the other, cursing all the choices we have in our country?
Active ingredient? Ibuprofen, ibuprofen. Dose in one tablet? 200mg, 200mg. Price? Depends on where you're at -- one shopper in Boston saw a difference of $5.49 to $3.49, so 57% more for the Advil.
Should you listen to your thrifty instincts and go for the bargain or dish out the extra dough for the brand-name? You have heard that "nothing works faster, stronger, or longer" than Advil, and you really want to get rid of this headache already!
Well you just wasted five precious minutes, because it doesn't matter. Here's why the two medications are actually the same, and why the prices aren't.
Generic drugs are required to do the same thing as their name-brand equivalents
When the Food and Drug Administration (FDA) approves your generic meds, it's specifically comparing them to the brand-name medications, which always come out first (more on that in a bit).
Therefore, it's unnecessary for you to repeat the comparison exercise in the pharmacy aisle. The FDA has already checked that the drug has the same active ingredient, the same strength, the same dose, and the same route of administration -- this is whether the drug is going in your mouth, being applied via skin patch, getting sprayed up your nose, etc. And no offense, but it's a bit more of an authority on this than you are.
The differences are mostly irrelevant
There are some aspects of a medication that are allowed to be different: the inactive ingredients, the name on the box, the style of the packaging, and the shape and color of the pill. In other words, the things that shouldn't affect how the drug works.
However, because generic-drug producers know that people like you freak out about this kind of thing, some make the pill look exactly the same just so that you can relax and feel better about it. "Patients sometimes report that the brand-name or generic medication works better for them, or is better tolerated," says Dr. Wayne Altman, vice-chair and professor of family medicine at the Tufts University School of Medicine. "That can be a placebo effect for the patient... I inform them that there's not a likely reason that it should be any different."
There's a caveat with inactive ingredients, but it goes both ways
The only caveat to the totally equivalent concept is that inactive ingredient list. This isn't the chemical that's supposed to make you feel better, but what else needs to be added to the medication to hold it together.
In a capsule, for example, the powder inside might contain the drug itself, while the gel containing the powder could be made of inactive ingredients. "Sometimes the inactive ingredient will affect the delivery of the molecule in terms of how quickly the body will metabolize it," Dr. Altman explains. "Patients could feel an effect quicker or slower."
But, he points out, this difference can go either way -- "Patients may idiosyncratically respond better to one form of a medication than another." In fact, he has patients who will ask him for a specific version, but it's not always the most expensive one. Switching prescription medications should obviously be discussed with the doctor, but for most conditions, it doesn't end up making a difference.
To prove themselves worthy, companies test something called "bioequivalence"
A generic-brand manufacturer can't just say the drugs are the same and have the FDA call it a day. The agency has strict requirements for how the drugs need to be tested for bioequivalence.
This is a testing process that compares how the generic and brand-name medications act in a patient's bloodstream by having one group of patients that takes the brand-name and another that takes the generic.
Study participants take the med, hang out and waits however long it's supposed to take for the drug to get absorbed into the bloodstream, and get pricked for a blood test to measure how much of the active ingredient is present. The patients then gets more blood tests as time goes on to see the changes in the concentration of the drug in the bloodstream over time. Then, they may even repeat the same study the next day, when they switch groups and get more drugs and more pricks. Overall it sounds like a great time.
The idea here is that even if different drugs say they contain the same amount of ibuprofen, for example, that number isn't nearly as important as whether it shows up in the body in similar amounts.
Even though the FDA allows a window of difference, a review of over a decade of brand-name versus generic bioequivalence data submitted to the FDA -- that's more than 2,000 of these fun little studies -- showed that the amount of drug in the bloodstream only varies by 3.5% on average.
Why don't brand-name drugs just knock down their prices?
In a nutshell, brand-name drug makers have to pay for much, much more work. Generic producers simply demonstrate that an active ingredient works just as well as the original formulation, and once they do that, they can start making money.
Pharmaceutical companies producing a brand-name drug -- the first one on the market -- are the ones starting from zero.
First they have to somehow come up with a theory of what chemical will help you get rid of your headache/heartburn/constipation. This already involves a bunch of experiments. When they have a solid theory, they can move on to animal testing. After they show that the drug isn't harmful for the animals, and does have the effect they were looking for (does not turn mice orange, does make them poop), they're allowed to move on to clinical trials with actual people. They conduct phase 1, phase 2, and phase 3 clinical trials, and only then can the drug be approved by the FDA.
But even after approval, it's possible no one wants to buy it -- who wouldn't be skeptical of a medication that just came out? The pharmaceutical company has to invest a fortune in advertising to convince people that its drug is really OK, and can in fact help them.
When all's said and done, it's totally in the red, having spent about $802 million over 10 to 15 years with no sales, the people who started developing the medication probably retired by now. Needless to say, that spending somehow has to be recouped.
Of course, this is a far greater concern for prescriptions and novel treatments for serious conditions. When it comes to getting rid of your headache or constipation, there's not nearly as much of this residual research-and-development cost to consider.
The good old USA lets the cost difference happen
Researchers at Harvard decided to figure out whether the high costs of brand-name medications were actually fair, even given this expensive development process. So naturally, they conducted a study, which found that when it comes to prescription meds, Americans spend more than double of what people spend in other industrialized countries.
This is largely because the US has a pretty unique system of patents and price-setting for pharmaceuticals. When a company first makes a medication, it has a certain number of years of market exclusivity under patent -- it's a monopoly where only it can sell the drug, because it invented it -- and there are tips and tricks for extending that time to 20 years or longer. (The people who started developing the drug are not only retired, but dying at this point.)
The US is also different in that pharmaceutical companies can set their own prices without negotiating with the government. Instead, they just decide what the drug will cost based on market demand, which usually ends up being much higher than what would offset their development costs, because patients need medication.
Again, this is especially important to remember for prescription meds, but it makes buying brand-name over-the-counter meds even less of a smart choice, considering how long these drugs have been on the market. Ibuprofen, for example, was discovered way back in 1961, and acetaminophen's been around since the 1800s.
Don't be one of the people who doesn't get it
In the year 2015, the purchase of generic medications over the brand-name ones accounted for $227 billion in savings for the US as a whole. This means that if everyone had chosen brand-name meds, we would have spent hundreds of billions more as a population.
But there are people who do continue to choose the brand-name versions because they think they're better. In one study, college students reported better headache relief and fewer side effects from pills that were labeled with a brand, compared to pills labeled generic -- even if both versions were just sugar pills! You'd think that college students, of all people, would value cheapness.
These results shouldn't be dismissed; after all, the placebo effect is powerful medicine in its own right. If you're someone who thinks that Advil always works better for you, consider the possibility that you're seeing a placebo effect instead. If that's the case, just imagine the generic is actually a brand-name drug, and you should be good to go.
On the one hand, you might say, "Hey, if people want to pay more for brand-name drugs when cheaper options exist, that's on them." But generics don't just affect individual consumer choice; cheaper drugs mean savings for everyone from patients, to hospitals, to insurers, and they help keep patients on an appropriate course of treatment.
All that means more time and money can be spent on preventing and treating disease, which helps ease the strain on the entire health system. "I don't like to be wasteful with the resources of our health care system," Dr. Altman says. "It may be an added expense for the patient, but it's definitely an added expense to the system."
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