Reuters reports on a new birth control product, still in development phase, that showed good efficacy, at least according to an unpublished company study. The product, a gel that lowers vaginal pH to make a hostile environment for sperm, would add a new contraceptive option to a lucrative market.
However, the story focuses on company success — increasing stock value and stoking excitement in investment circles — more than the specifics of the product or the details of the company-sponsored study. No study limitations are mentioned. This leaves both investors and lay audiences without enough information to evaluate how useful the new product will be, should it pass muster with the FDA.
There are a wide variety of birth control products on the market, but there’s also plenty of room for something new. A product that’s easy to use, effective, with few side effects, and that women control — the birth control gel sure sounds like it could make an impact. However, future consumers will want to know a lot more information than was provided in this story — how much will it cost, will it be available over-the-counter, how effective is it in real use, will side effects crop up once it’s in wide distribution? With an as-yet unapproved product, these answers won’t become clear for awhile, yet we think they should be considered — for consumers and investors alike.
The story does not mention what the cost might be for the new birth control gel. It’s a useful bit of information in the birth control market with products ranging from a couple dollars for a condom and hundreds of dollars for an IUD. Reporters can ask for estimates or cost-comparisons even for products that are not yet approved or on the market.
The story briefly describes a study in 1,400 young women, from which researchers calculated that the gel had an 86% efficacy rate — a common measure of birth control efficacy. However, it could have explained that better: In the contraceptive research world, this generally means that the failure rate is 14 pregnancies per 100 women in a year. But researchers only studied the gel for seven menstrual cycles.
The story compares this pregnancy rate to a couple of of other forms of birth control, which is good, but it’s worth pointing out that those failure rates have far more evidence behind them. The efficacy rate for this new product is based on just one industry study.
Also, the story makes a vague reference that the gel may kill “certain viral and bacterial pathogens that can cause sexually transmitted diseases.” Only at the end of the story do we find out that researchers have no data yet for this claim.
We’ll give this a just-passing satisfactory score because side effects were briefly mentioned: “no serious side effects were observed in the study.” Still we’d like to see mention of less serious side effects, especially for a birth control intervention, because they’re often a significant factor in women’s choices.
The story gives some study details, regarding the subjects. However, we don’t know the study’s duration, which could affect side effects and efficacy. No mention is made of how the product is used or how compliant study subjects were, which are two key factors for any birth control method. Also, the study details were provided by the company, not by an independently run study, although the story notes this. The fact that the study hasn’t been published and peer reviewed is also not mentioned.
With a new birth control product, we’d like to see comments from independent physicians or researchers that are experts in the field–and we think this is something investors would value seeing, too. However, this story quotes the CEO of the product’s maker, as well as two business analysts.
The story mentions other birth control products, such as male condoms and birth control pills.
However, the story sharply misleads readers by claiming that the positive results with the gel brings: “the first hormone-free contraceptive close to approval.” That’s simply wrong. Current hormone-free products include male condoms, copper IUDs, diaphragms, and cervical caps.
The story makes clear that this a product under development, not yet approved or marketed.
The story describes how the new product differs from male condoms — “woman-controlled” — and how it differs from oral pills — “non-hormonal.” But this isn’t novel, as we describe in alternatives.
Although testing is still underway, as the story notes, what’s interesting is that the gel may have some effectiveness against some sexually transmitted diseases, which would make it different from most other forms of female-based contraceptives. We think the story should have provided more information/evidence about this claim, though.
The story appears to go beyond the company news release.
Systematic, Criteria-Driven
With the discontinuation of @HealthNewsRevu, there's a genuine concern that well-written and researched "reality checks" in healthcare are not economically interesting. This should be disconcerting to anyone, and yet I'm only seeing more and more piling into "promising findings"
Thanks for ALL you do and have done, Gary. https://t.co/93K4hzQXZj
Thanks for sharing this with all of us today, @garyschwitzer @HealthNewsRevu
A nice gift.
#healthcare #healthcarenews #journalism #reporting #factsmatter #truthmatters https://t.co/hNHdZDl2rc
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