Last week Public Citizen petitioned the FDA to ban Ortho Evra, the birth control patch, stating
the amount of estrogen released from the Ortho-Evra patch varies widely among individual women, and those who absorb too much were at greater risk for blood clots and and other painful side effects."The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho-Evra as a contraceptive," wrote Sidney Wolfe, head of the research group.
This is just the most recent move in a long history of controversy over the patch. And looking back over the Feministing reader birth control poll, some of you out there are using it. Personally, I used the patch for 6 months when it was first released, to very mixed results.
What do you all think about the possible ban? The FDA is unlikely to do anything, they contend that the risks are well known, and properly disclosed. Is banning Ortho Evra the right move?
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I'll be really disappointed if it gets banned. I've used it for a year and it's the first method of BC I've really liked and had no problems with.
I have used the patch for over two years, and have had very few issues with it. The only thing I don't care for is fuzz from jeans/panties (anything cotton) tends to stick around the edges of it, but a bit of baby oil on a q-tip will get that off. And I have only had one ever fall off, but was able to get a replacement that day at the pharmacy. Other than that I have had no medical issues with the patch, and love the convenience of only changing it once a week. So much easier to remember than the pill. I did notice the first time I started the patch I did feel somewhat sick to my stomach for a day, but I haven't had any problems since.
I used it for two years and really liked it. I'm over 35 now, though, and no doctor will write me a script for it now. (I've asked 3.)
I will say I wish the Mirena was getting the same level of scrutiny. I had one placed after my second baby was born, and had to have it taken out within months. The doctor who removed it said she has had a lot of women experiencing problems with it.
I've used it for three years without any problems. On the other hand, the nurse at the sexual health clinic here says that the patch in Canada (where I am) is considerably lower in dose than the patch in America. I wonder why? Has anybody else heard this?
From the other side of the patch, as it were, I've had many, MANY patients who have loved the patch and not had any problems-- certainly not as many as they had from the pill.
There are definitely some people who just aren't good candidates for the patch. I think the problem lies in a medical system that a) doesn't devote sufficient time, money and attention to reproductive health issues and b) educates healthcare providers on new contraceptive methods through the drug-rep-trend-of-the-week school of medicine. Thus your average healthcare provider prescribes a limited range of contraceptive options because they aren't being exposed to updates on existing contraceptive options (sub-Q Depo, new varieties of birth control pills, etc.) and may not have a drug rep to talk to them about new methods (both pro and con, as with Mirena).
And sadly, drug reps are the way a LOT of (if not most) healthcare providers get their information.
Clarifying comment-- I reread my post and realized that I made it sound like all my patients had problems with the pill. That wasn't what I meant. I had a lot of patients who switched to the patch after trying other methods, like the pill, and having problems-- from increased appetite to inability to remember to take it on time. Sorry 'bout that!
Maybe it works differently for different people, but I've been using the patch for 5 years and it has worked amazingly. Yeah, the patch itself might not look nice at all at the end of the week but I'll rather have this happen to me than get pregnant. I would be really pissed if they discontinue the patch... its the best contraceptive for me.
When I read the article about Public Citizen asking FDA to get rid of the patch my response was NOOOOOOOOO!
I've been on the patch since I started having sex 5 years ago and I love it. I know I couldn't remember to take a pill every day, but I can remember to change the patch every week. I also really like the fact that I can see and feel it--I know some people wouldn't like that, but I really appreciate being able to easily confirm that it's there. I've had a few patches fall off, but if you replace them within 24 hours you're fine, and I always noticed and replaced them right away. The one thing I don't like about the patch is that because of the high hormone levels my doctor won't let me use it continuously to avoid having periods. She told me I can use two boxes back to back (so I'd go six weeks between periods instead of 3) but no longer. I thought about switching to a pill to avoid periods, since I really dislike them, but on balance the patch and periods was better for me than the pill with no periods, for a lot of reasons. I can't imagine what I'll do if they do succeed in getting the patch banned. I've been worried since I heard about these efforts.
btw, does anyone on here use Implanon? I've seen a few things about it recently and am curious to know what people's experiences with it are.
For those who use it and like it, I admit that it will be a pity if it is banned, but I have been worried about the delivery method. (I happen to almost certainly have a genetic blood clotting disorder, which I only know about because a family member is a geneticist who got tested for it.)
Personally, I had to give up on the pill, and I don't think other hormonal contraceptives would work well for me even if it weren't for the blood clotting issue.
I don't think there's a single kind of birth control that works for every woman, or is safe for every woman. Banning one method just reduces our options. Mirena (an IUD) that one woman above complained about, has been the best birth control I've ever used. Various pills, which millions of women think is their personal savior, are a nightmare for me. The patch might be dangerous for some women, but it's perfect for others. If your ob/gyn isn't working with you to try things till you find the right one, then you need a new ob/gyn.
I certainly don't trust the FDA to find the right bc for me.
I always feel weird and hesitant when I hear of a BC option being banned--or about a proposed ban. It seems to me like it's a slippery slope and a path to something more sinister than "public safety." I mean, if "they" can ban one method of BC, then they will go on to attempt to ban others.
That said, is it safe? I don't know. Seems a lot of women use it with no problems, but we don't always HEAR about problems, either, especially when they first start showing up.
I have a very sensitive body. I do not (and probably won't) use hormonal BC for that reason; however, when I see our options being limited, I worry about other motives on the part of those doing the limiting.
Jen M.
I've used the patch for 3 years and love it. Besides birth control, it also regulates my periods better than any type of the pill I ever took. (This is the only reason my health insurance covers bc, btw; without something to regulate my cycle, my periods are horrendus.)
I was informed in January, however, that Ortho Evra will no longer be covered regardless because of all of the health concerns. Once again, I have to go "shopping" for bc when my script expires. Considering the patch works so well for me, I am none too pleased.
I think this is a really complicated issue. Many individual women may have good success with and good tolerance of the patch--perhaps even better than with various forms of the pill. I'm a big fan of that--anything that helps women control their own lives ranks very high on the list of positives for this drug. I was on this briefly when it first came out, and while I couldn't stand it, I know others who found it very convenient.
However, when we consider this issue from a public health standpoint, the calculation becomes murkier. Women die on this product. Women die on this product at a much higher rate than on other, comparable products. As far as I know, we don't have any way of determining which women are more likely to suffer this consequence based on medical history, etc. We can detect genetic clotting disorders. We can recommend against smoking when prescribing this product. But other than that, I don't think we have the data to show whether we can prevent or minimize this adverse effect and still keep this product out there. Pharmaceutical companies have no incentive to produce these data because it would reduce their market share, and the cost of the trials make it unlikely that anyone else will undertake to do so.
But even if we did have this data, we would still see adverse events. Patients get prescribed drugs that are clearly contraindicated for their condition all the time. As a previous commentator noted, doctors get a lot of their information about drugs from pharmaceutical reps, who have an incentive to minimize negatives.
So given all of this information, how do we protect the women who we know in advance are going to die from taking this medication, but whom we cannot identify in advance? How do we convey the magnitude of the real risk?
Let's also not forget that not only are there pills on the market, there's also another product (NuvaRing) that provides similar convenience in terms of not having to take the pill every day. So the number of women who will be truly inconvenienced by removing or limiting access to this drug is low.
I won't purport to say that I know the right and absolute answer to this question. But I will say that I think that the system is broken, and that OrthoEvra reflects that at some level.
Also, in the interest of full disclosure, I used to work for this part of Public Citizen. But as much as I think they're generally great, I'm not trying to shill for them. I honestly have very mixed feelings about this.
It's a hard issue. If the dosage is truly as unpredictible as the article states, then perhaps pulling the drug is the safest public health option. Dosage with drugs is a huge issue, and if it can't be determined then the drug is not reasonably safe to be in the market.
But if it is just as unpredictible as other, non-BC drugs which aren't banned or under review, then it's not a great idea to pull it. That is to say, if the unpredictibility is sufficiently rare, and that amount has been OK'd by the FDA for non-BC drugs, then it's sufficiently safe to keep on the market.
I guess what the FDA really needs to do is a comprehensive risk assesment study. And, you know, get their heads out of their asses about women's health. But that's a whole 'nother post.
I've been on the patch for 5 years and I've never had any problems. I've been on various pills and depo since I've been sexually active and the patch seems to work best for me.
I am a little concerned about all this information, but I don't know if banning it is the right way to go at all.
I think the problem lies in a medical system that a) doesn't devote sufficient time, money and attention to reproductive health issues and b) educates healthcare providers on new contraceptive methods through the drug-rep-trend-of-the-week school of medicine.
Very good points. And Sara, I use the patch continuously to skip my periods and my clinician told me it was fine.
Also, I don't think the nuvaring is comparable at all. I used it for a month before I started the patch and I hated it. I don't think having a piece of vinyl just hanging out in your vagina all the time is really comparable to the simplicity of the patch.
Also, what are the warning signs of blood clots?
I would CRY if they took away my patch. I started on it 3 1/2 years ago and haven't had any problems. I took a couple of months off in order to try Lybrel and haaaaaaaaaaaaated being tied to taking a pill every day (not to mention that it gave me a TWO WEEK PERIOD. Yeah, totally NOT why I switched!). I quickly switched back to the Patch and love it love it LOVE IT. Like a few other people have mentioned, I use it continuously to stop my period (like Lybrel should have), with my doctor's blessing, and haven't had a single problem.
Can you tell I love my patch?
good points, leah and mernlar.
I wonder how these variable rates of horomones are absorbed or released by the patch. Could a reformulation of the patch fix the problem? While I've never been on it, I wonder if they could do something that Orthotricyclen did- the normal pill, and then the Orthotricyclen "Lo", which had less horomones or a slower absorption rate. For women who absorbed too much of the horomone, it might be a nice option to be able to pick a lower horomone alternative.
On a side note, my gyno told me not long ago that if ALL birth control options went on a lower horomone dose, most of the obese or heavily overweight women she treats would not have a birth control option... scary!
I personally don't know enough about the patch to have an idea of whether it should or should not be banned. I will say that from personal experience, it is the only form of hormonal birth control that I tried that I would never use again and would definitely recommend to other women to use it with extreme caution. I used it for two months. I bled heavily for the entire two months and I've NEVER felt sicker. It made me so sick I honestly began to wonder if I might be dying at one point. One of the worst experiences of my life.
I am a bit torn. I am excited by the availability of a variety of drugs to suit everyone's needs. But I am concerned about drug companies (like J&J with the Ortho Evra) concealing info to get FDA approval, since the Supreme Court may soon decide that FDA approval shields the manufacturer from liability for resultant injury/death. If the agency is as understaffed as the article mentions, and can't properly do its job, maybe outsiders should be watching them.
Lyra-
According to WebMD (http://www.webmd.com/dvt/deep-vein-thrombosis-dvt-symptoms-diagnosis, sorry I don't know HTML), over half of DVTs (deep venous thrombosis) do not cause symptoms. However, they do not a few things, such as abnormal swelling in extremities, pain, cramping, redness, vein prominence, and skin warmth as possible signs. They also recommend immediate trip to the ER if you experience sudden coughing, with or without blood, severe chest pain, or shortness of breath, rapid breathing, or severe lighteheadedness. These may be related to pulmonary embolism, which can be fatal.
So, all in all, not very useful.
Some thoughts about the studies they do on these things -- it wasn't clear from the links above.
First, have they controlled for proper use? I am not saying that users are stupid or whatever, but I know a lot of health professionals who run into people who don't follow the instructions exactly. Hell, I often don't. I make the same mistakes that lots of people do -- "If some is good, more is better" or "if it works well this way, it must work even better if I apply/ingest/whatever my way!"
Again. I am not saying the majority do this with the patch, but I'd be shocked if a few don't.
By the way, people also mess up instructions because they are hard to follow (or read. Do they think everyone has a bloody magnifying glass handy? Pet peeve).
Second, I am not sure I like the idea of banning stuff like this either. I love Public Citizen, but one should put in perspective what the increased risks are.
If I double my risk of heart attack in the next year, for instance I still only have a 0.5% chance of getting one. Lots of people don't read numbers well, and the Public Citizen release wasn't clear -- to me anyway, on an admittedly not super-careful reading -- how whatever risks they found bear on the total population of users.
It's sort of like using bc pills-- spread out over the whole population of women that has used them the risks aren't all that great (assuming the pills are prescribed the right way by a good doc) -- certainly less than a host of other drugs. (Or bc methods for that matter -- remember the first generation of IUDs? I know a few GYNs that shudder still).
So on balance, I'd say leave them on the market and make sure your GYN knows what s/he's doing and by seeing that they do all the stuff good docs are supposed to do.
Public Citizen is a data-based consumer advocate group, and I take their recommendations seriously in making decisions for myself. However, the points brought up by other commentors re: individual's weight and due diligence on the part of gyns are certainly valid. I do not support the ban even though I understand the risks. As somebody who is skinny and over 35, I am not a candidate for the patch. Others, however, might be.
I want to add to everyone who loves the patch and would be disappointed if it disappeared: I understand. If my choice vanished from the market, I'd be really damn upset. But you have to keep in mind that your positive experiences don't mean you are not at risk for blood clots or cardiac events. Everyone should remember that for all drugs they are taking.
On a side note, the Public Citizen home page has a sexed up picture of a woman wearing the patch on it:
http://www.citizen.org/
My teeth are gnashing.
I find it really interesting that there is this huge hoopla about the excess estrogen in the patch when we often unknowingly imbibe large amounts of hormones through treated animal products and cosmetics. http://www.nytimes.com/2006/10/17/science/17puberty.html
The adverse effects of this are debated (though it makes sense to me), but I feel like the real point is that a BC patch is getting tons of scrutiny, but other hormonally related health risks aren't.
Makes me realize more than ever that the issue here is not so much women's health (otherwise wouldn't precocious puberty be getting more serious attention) as it is yet another excuse to insert the thin edge of the wedge of restricting women's access to BC.
If it was to be baned I would be concerned to say the least. I suffered from extremely painful migraines and painful cystic acne for several years after puberty. I have been on the patch for almost a year now and I have been pain free for 10 months. I fear that other forms of birth control would not contain enough hormones to help me.