What is the difference in cheap and expensive oral contraceptives?

In My Humble Opinion
1

In all the brouhaha over Limbaugh in the past week much of the actual argument over birth control has been forgotten, but a point raised in a couple of (more rational) editorials against the mandatory inclusion of no-co-pay birth control mention the cheapness of it. Tri-Sprintec, for example, is available for less than $10 at Target and Wal-Mart. However, numerous charts and figures show that other forms of birth control can run up to, perhaps even over, $100 per month.

What factors warrant the huge price difference between the ~$100 per month and the <$10 per month forms of oral contraceptives? Are the more expensive forms more effective in preventing pregnancy, or do they have fewer side effects, or…?

2

Each woman reacts differently to each kind of birth control. The cheap one you mentioned, Tri-Sprintec, and others with “tri” in the name change the level of hormones you get each week while others give you the same level of hormones for 3 of the 4 weeks and still others keep you on a stable hormone level for 3 months at a time. They all prevent pregnancy but they work in different ways.

For example, when I was on Ortho-tri-cyclen it did an excellent job of preventing pregnancy by sending me into crazy, murderous rages 7 days per month. Yasmin kept me perfectly sane all month long but drove my blood pressure through the roof. I’ve since given up on oral contraceptives and I just had my tubes tied so as to not have to deal with all of the stuff that goes along with the pill but for women who can’t have/don’t want a surgical birth control option they may have to try half a dozen or more different versions of the pill before they find one that works for them.

3

First, of course, there’s the generic vs name brand difference. And if someone can tolerate the generic version, great, but if a patient is sensitive to certain ingredients, not so great. Generics often don’t use the same inert ingredients between one batch and the next, and this can affect some patients. This goes for ALL medicine, not just BC pills. So if a medicine doesn’t have a generic version out yet, the manufacturer will charge all the market will bear, for as long as possible.

Even with name brand medicines, some are known to cause more side effects than others. And some patients may need different doses, or need ingredients in different proportions to each other.

4

I have no experience with contraceptives of course, but it sounds a bit like when I was on antidepressants. What works for my friend might make me more depressed than I was before or vice versa, or this one works fine on the depression but makes me feel like I’m crawling out of my skin or totally kills my libido. I went through about five before I found the one that worked best for me.

Since I was fortunate enough to be on insurance when I started on them I never really asked the price since the co-pay was the same regardless. When I went to grad school and was no longer covered (I was over 25 and the student health insurance only covered routine doctor’s visits and ER [and was still expensive], didn’t cover prescriptions) I had no choice but to change it to another strictly due to $- it was the difference in $100 per month and about $40, and of course didn’t work as well.

5

Yes, that sounds like a good comparison to birth control. Hormones can mess with you just as badly as psychoactive medication.

As for the huge price differences, I dunno. Copyrighted/not copyrighted, generic/brand name etc.

I was on a bc pill for a while that perfectly mimicked morning sickness. I couldn’t go into grocery stores while I was on it, and was never able to eat a whole meal at a time. Then another killed my libido. The one I’m on now gives me breakthrough bleeding, but oh well.

6

I started on Ortho-Tri-Cyclen as my first or one of my first contraceptive pills. Considering that my first reason for being on it was to try to prevent or minimize the agonizing menstrual cramps I’d get 3-4 days/month and that it didn’t really help all that much, in my case it was not a good choice to continue on once it became obvious things weren’t going to change. I didn’t have any noticeable mood or other adverse effects, though.

(Seriously, I really did want it for that reason. I wasn’t sexually active in high school and once broached the subject of the Pill for cramps with my mom, and her reaction was just so awkward about it that I didn’t try again. Which sucks, because she saw what agony I was in each month, and I popped as much Midol or whatever else I could get my hands on as I dared, and that only brought it down to bearable. Once I got to college and realized I had a student health service and student insurance that was mostly paid out of tuition, with small copays for drugs and other things, I got in to be evaluated to be on the Pill right away.)

Yasmin never screwed with my BP, but I have consistently low BP anyway.

Those pills with varying hormone levels can’t be taken continuously (no placebo week, no time off) if your doctor thinks that would help you with some kind of problem, so that’s another drawback to those. A couple years ago, I went on Yasmin continuously at the advice of my gynecologist and neurologist to try to stop the migraines that I started getting along with my period. That worked for a while, but after the period started coming anyway (and migraines with), we switched to a hormonal IUD and that’s been great so far.

So really, it all depends: Are you only using it for contraception, or do you have other reproductive/menstrual/hormonal related health issues that this is needed for? Are you suffering side effects from the current pill that might be fixed by switching?

7

Unless you mean 'from one manufacturer to the next" instead of batch, this is 100% false.

A given generics manufacturer making a given pharmaceutical product will absolutely use the exact same recipe (formulation), ingredient proportions, manufacturing process, equipment types, testing protocols and other validations of product identification and quality each and every time they manufacture it. Even for a generics company, it takes years of testing and equivalency data before obtaining approval from the FDA (or equivalent per country) to sell the drug on the market, and any formulation change also takes years of work and documentation to support to ensure safety, stability and efficacy.

The formulation might change between manufacturers - one might go with 33% lactate, the other with 30% lactate or whatever variations on inert ingredients - but the dose of active ingredient will be the same as labelled and must be shown to be true in terms of stability and bioequivalence as compared to the brand name.

Generic drugs aren’t just a cheap toss-whatever-in alternative to brand names; they are spared the cost and effort of the preliminary R&D, but the work that goes into getting the drug approval and the continuing stability and validation once the drug is on the market is pretty much identical.

The more expensive products are both brand name ones making money by being the brand name and also newer products that are still under patent. Newer products aren’t always the same as older ones - small chemical differences in the hormones used, different ratios of hormones, new hormone types entirely, possibly some potentiating ingredients… there are a lot of ways that new products entering the market vary from the existing ones, same as with other forms of medicine. New drug discovery and design is a huge market and the increased cost reflects the R&D time and effort out into making the new drug variation.

8

Yup, it’s exactly like that. So the $9 Target brand is kind of like if they had one antidepressant on their list and it was generic Paxil. If you can work with Paxil - GREAT. If you can’t there’s nothing for it, you have to try something else.

A lot of the most expensive options are actually novel delivery mechanisms, rather than novel formulations. So, for example, the Nuvaring, a hormone-infused flexible plastic ring you insert and leave for thirty days; Orth-Evra, a transdermal patch; Seasonale, birth control pills packaged to facilitate “period skip through” (taken as directed, you will have only 4 periods a year).

9

I’ve heard that generic drugs, even from the same company, are not required to use the same inactive ingredients from one batch to the next. And I know that pharmacies will fill the generic prescription with the cheapest drug available, and this might vary from one month to the next. In fact, this is a known problem, as some people are sensitive to some of the inactive ingredients. I had to quit getting generic thyroid supplement, and go with a name brand to avoid this.

My Google-fu is lacking tonight, so I can’t dig up anything that says whether or not companies have to use the same inactive ingredients from one batch to the next, and I’d like to see a couple of links that have more info on this.

10

The taste?

11

Having worked in pharmaceutical development, analytical chemistry and quality control for both brand name and generic pharmaceutical products I can absolutely attest that you were misinformed on this point. There’s no other way to say it - it’s wrong. A generic manufacturer will follow the same procedure for lot after lot of drug and they are all the same, right down to the inactive ingredients. Changing the recipe changes the drug and new validation and approval needs to be met.

Sometimes companies - brand name and generics - will change the supplier of an inactive ingredient, but the inactive ingredients will also be held to the same level of quality standards as each other so that there is absolutely no difference whatsoever in the final product.

This is a different issue that I don’t really have experience with the laws and practices. It’s possible - indeed probable - that pharmacies will source and sell different generic drugs and will supply the least expensive one to patients. What’s happening here, though, isn’t that the drug coming from (for example) Apotex is different all the time, but rather that one day you’ll get the Apotex generic, then next time the Sandoz generic, then next time the Pharmascience one, etc. Although they are all generics relative to the original brand name - that is, they contain the same active ingredient and are statistically bioequivalent to the original patented drug - they are different drug products with their own histories and approvals and, yes, different inactive ingredients.

It’s unlikely that all generic thyroid medications caused you trouble - but perhaps one or two did. There’s no need for you to go around experimenting with your health by messing around with shopping for meds, but if you wanted to you probably could find a generic that suits you exactly the same way the brand name one does.

12

At least one generic brand did give me trouble, and at least one different brand didn’t give me trouble. But the pharmacy and my insurance company REALLY gave me trouble for wanting to have the same (generic) brand all the time. I’ve since switched both drugstores and insurance companies.

I’m pretty sure that it was a pharmacy tech who told me that the inactive ingredients were subject to change from one batch to the next. Yeah, I know the difference between the tech and the pharmacist, but I would expect the tech to either know such things or know that he didn’t know.

13

Well there you go. It’s a shame that the pharmacy and insurance situation means you are pretty much forced to pay more for your medicine even though an alternative is available.

In an ideal world, eh? :slight_smile:

From what I’ve understood, even pharmacists don’t spend a lot of time on the details of production and approvals in pharmaceutical companies, though this is something I’d expect the pharmacist to know. I wouldn’t necessarily expect it of a tech, though, based on the educational requirements for them that I’m aware of.

Perhaps the simple confusion of “batch” and “manufacturer” plays into this - I think people tend to think of generics as being one big mess of lower-quality stuff, when it really isn’t that way at all. Each generic product from a different manufacturer isn’t a different batch it’s a different drug sharing the same active ingredient, bioactivity and used to treat the same issues. All batches (lots) made by one manufacturer will be the same. They are drug products in their own right, with all the testing and work gone into it, same as the brand name. It’s all a matter of marketing and packaging, with the initial development R&D rolled into it.

14

I wonder if he might have been using “batch” not in the sense of “lot from one particular company” but in the sense of “what company we went with when we placed the most recent order.” I’ve done that myself when explaining to someone why their dog’s pills look different from what they’re used to, if there was a special and we got a different generic than we normally use.

15

Just wanted to thank mnemosyne for the excellent ignorance fighting! I learned something today (so can I go back to bed now?).

16

I’ve looked into this matter.

[ul]
[li]The term for a patent is 20 years. Anything that has been on the market before 92 should be in the public domain. Drug companies constantly tinker with their recipes and get new patents, but the original formula is still in the public domain. [/li]
[li]There are countless anecdotes about how this birth control or that has terrible side-effects, but I haven’t found a single peer reviewed double blind study documenting these problems. This makes perfect sense, since drug companies have no incentive to help woman find cheaper birth control. One double blind study on anti-depressants found they where no more effective than placebos except in cases of severe depression.[/li]
[li]Progestin-only pills probably have the least side-effects, but they are more complicated in that you have to take them at the same time every day and not take them during your period. Some implants like Implanon are progestin only. [/li]
[li]Some people take certain kinds of birth control because of positive side effects. They experience decreased migraines, cramps or bleeding with the birth control they are using.[/li][/ul]

17

Aww, thank you. I appreciate the recognition.

And yes, you can go back to bed if you haven’t already - I consider one thing learned per day to be sufficient justification for a nap.

[quote=“JoelUpchurch, post:16, topic:615015”]

I’ve looked into this matter.

[LIST]
[li]The term for a patent is 20 years. Anything that has been on the market before 92 should be in the public domain. Drug companies constantly tinker with their recipes and get new patents, but the original formula is still in the public domain. [/li][/quote]

I am definitely not an expert on this at all, but I’m not sure it’s quite that simple. If a drug is found, once it’s on the market (or information/studies are deliberately delayed) to have a use to treat another disease entirely without making changes to the formulation at all, it is possible to obtain a patent extension for that purpose, but I’m not sure of the details. This is something that happened with Wellbutrin and Zyban - the initial drug approvals for use as treatment for depression gave a certain amount of patent protection with an extension granted when it was launched as a smoking cessation aid (or vice versa, I’m going by memory here!)

[quote]
[li]There are countless anecdotes about how this birth control or that has terrible side-effects, but I haven’t found a single peer reviewed double blind study documenting these problems. This makes perfect sense, since drug companies have no incentive to help woman find cheaper birth control. One double blind study on anti-depressants found they where no more effective than placebos except in cases of severe depression.[/li][/quote]

Most drugs aren’t approved for use on the market based on their performance in comparison to another drug, they are approved based on their ability to treat the medical condition in question as compared to no treatment or a placebo. There are comparison studies out there - and manufacturers, particularly brand name ones - are interested in the results for marketing purposes, but they aren’t reflective of the process to get a drug on the market in the first place. (Does that make sense?)

Anecdote != data. Some people will experience side effects that others don’t, some will experience positive effects, some will experience worse effects. Human biochemistry is actually rather variable - diet, disease, genetics, random factors come into play when seeking to understand how the body reacts to a drug. When side effects and efficacy of a drug is studied in clinical trials, the data is collected over a statistically significant population, not just in single individuals. So while I avoid taking Midol, for example, because it makes me weirdly woozy, it’s fantastic for many people and my reaction to it doesn’t actually mean there is anything wrong with it and that it ought to be avoided.

As with all science, it comes down to good experiments and a good statistical understanding of the data obtained. There is an enormous amount of data that is examined before drugs even get close to approval. Generally speaking, I trust the process.

18

Yep, you simply cannot make changes like that in a GMP environment. I’m imagining the sheer amount of paperwork involved in just a fairly simple deviation in small-scale, NCSS-phase GMP. You do not make changes to a validated route, especially not on a manufacturing scale, without a damn good reason and even then you try to work in the confines of the batch record. You might be able to play with palladium catalysts, for instance, if there isn’t a specific source of palladium named.

19

Other things as well. The use of colchicine for gout is a recent example of a company being able to get a new exclusivity agreement because they did the studies and are now charging like crazy. You see the same thing with extended-release gauifenesin which suddenly started getting marketed like crazy as Mucinex. Changes like an extended-release formulation or a drug mixture can be used to extend patent life on an API as well.

20

Good example - it’s a rather interesting case given as colchicine has been around forever.

I haven’t really worked in pharmaceuticals since 2007 - I got the crazy idea in my mind to become a mechanical engineer instead of chemist - so I’m really not up to date on what’s going on in the industry right now, though I am following the major news somewhat.

One thing, though, coming out of the FDA 483 and manufacturing slowdowns at Sandoz is a good example of things that you just don’t change without full validations. Here’s a quote from the FDA letter regarding equipment used at a Colorado facility. The redactions are from the FDA.

Bolding mine. The company started using a nearly identical piece of machinery to the one that they had already been using (I don’t know what machine it is, I can’t figure it out) - probably an updated model of a common piece of equipment.

That’s just a piece of equipment - like changing your hand mixer and having the next cake you bake be a little fluffier (perhaps a little more serious; as I said, I don’t know what equipment it was). You don’t even think twice about it in your kitchen do you?

The change wasn’t validated - the company didn’t prove that what seemed like a trivial change had no effect on the final product. It seems that dissolution rates were affected…which may or may not mean that the drug is less effective in the patient (could be a difference of just minutes to reach full release)… and there were even recalls over the years as a result of this. This is part of why the company is being forced to shut down production in order to correct mistakes - it’s HUGE and definitely not good for the company.

Swapping out ingredients just. isn’t. done. Everything is validated. Everything is audited; double checked when you do the work, reviewed for approval, ran through visiting audits by clients and/or government officials. You don’t vary what you do - if something seems to be misbehaving, you document an entire investigation on it. I worked at one place where our calculators were validated, to ensure that all our calculations were good (so that only human error could cause issues).

It’s been a while, but I’d say easily half my time doing any given lab test was taken up with complying to all the documentation needed to prove that I was following the method/instructions exactly. The other half of the time - if that - was actually doing the work.