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FDA release on Intrarosa approval omits important conflict of interest

Rating

3 Star

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

Our Review Summary

Female REPRODUCTIVE system x-ray viewThe US Food and Drug Administration just approved Intrarosa, a once-daily vaginal insert used to treat women experiencing pain during sexual intercourse. The news release states that the drug’s efficacy was confirmed in two 12-week placebo-controlled clinical trials of around 400 postmenopausal women. “Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse,” it says.

That was about the extent of the discussion in addressing benefits and quality of evidence, as there are no quantitative data given, and no mention of the study’s design and limitations. With such lack of detail, we also don’t know how concerned we should be with the drug’s adverse effects, which could include “abnormal” pap smears.

If the news release refers to studies that the FDA used to evaluate the drug’s efficacy, it would be helpful if the FDA included the journal name and date of publication of the trials that informed the approval. And then the news release should clearly break down the results of those studies — complete with quantitative data — for journalists and the public.

 

Why This Matters

Vulvovaginal atrophy (VVA) is a common condition affecting 50 to 60 percent of postmenopausal women. Symptoms include vaginal dryness, pain during sexual intercourse and irritation/itching. Intrarosa’s active ingredient dehydroepiandrosterone (DHEA), also known as prasterone, is already sold over-the-counter as a dietary supplement — which is not FDA-approved, as the news release points out.

Potential effects of DHEA on cardiovascular and brain health, metabolism and sexuality have been extensively studied for the past 20 years in postmenopausal women. Although short-term usage is not considered problematic, researchers are unsure if DHEA is safe with long-term usage or at higher doses.

Therefore, it is critical that our regulatory agency evaluates independent, unbiased clinical trials published in peer-reviewed journals. And if any trial has an obvious limitation, such as a short follow-up time, then it is the responsibility of the news release to highlight this, even in the wake of FDA approval.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Applicable

The FDA evaluates drugs without consideration of cost, so it’s understandable that they wouldn’t comment on it — and that’s why we’re rating this Not Applicable. We look forward to the day when any news release about a new drug — even one from the FDA — includes some mention of cost in its message. After all, the value of a new drug is a function not just of how well it works, but its cost-effectiveness. With the newly approved Intrarosa are we looking at $10 or $100 for each round of treatment?

Its active ingredient, DHEA, is sometimes used as a dietary supplement. On Goodrx.com, a bottle of 300 25-mg tablets of Natrol goes for $13.29.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release states simply, “Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.” No data are provided to back up this claim.

Without any numbers, it’s impossible to evaluate how beneficial the treatment actually is. How many women from the treatment group experienced this benefit? And although it’s difficult to quantitatively assess pain, it could still be addressed by scores (e.g. On a scale from one to ten, how bad was the pain before treatment and then after treatment?). Without any idea of how much pain was actually reduced, readers have no idea whether the advantages of this therapy outweighs its costs and risks.

This is a point that we recently addressed in one of our blog posts, since news releases put out by the FDA often miss the mark on this criterion. More details, especially in the form of quantitative data, are badly needed.

As a result, we give the news release a Not Satisfactory rating here.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Every intervention carries its own sets of risks. For Intrarosa, the most common side effects include vaginal discharge and an abnormal pap smear, according to the news release. But it doesn’t detail what “abnormal” means or explain what the implications are for women who receive such a result. It also doesn’t quantify the potential harms, including how many women experienced these adverse effects.

Furthermore, the clinical trials cited in this release lasted for only 12 weeks, meaning long-term effects were not investigated. According to the US National Library of Medicine, the active ingredient DHEA may be unsafe if taken in high doses or long-term. Researchers also say DHEA may cause decreased breast size, a deep voice, increased genital size, irregular periods, oily skin and unnatural hair growth in women.

Since the news release doesn’t describe potential harms or talk about the drug’s long-term effects, we give it a Not Satisfactory rating here.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

We wish the news release would have gone into more detail on what clinical studies were used to gain FDA approval for the product. All we know is that there were two 12-week placebo-controlled clinical trials in 406 healthy postmenopausal women between 40 to 80 years of age. We don’t know whether the trials were randomized and blinded, how the participants were selected, how the trials were run (assessment criteria, number of follow-ups, etc.) and whether the results were published in peer-reviewed journals. We also aren’t exactly sure to which studies the news release is referring or how to access them for additional reference.

Due to all these reasons, we give the news release a Not Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this news release.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release doesn’t disclose the funders of the studies the drug approval was based on. In the one study we could find via an online search, it disclosed that EndoCeutics sponsored the research. The first author of the Menopause journal article is also the President and CEO of EndoCeutics, while the second author is an EndoCeutics consultant and receives grants for clinical studies.

We feel this is a major conflict of interest that should have been highlighted in the news release.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

There is no discussion of alternatives in this short news release. There are many interventions available now for vulvar and vaginal atrophy (VVA), including hormonal and non-hormonal therapies.

Over-the-counter treatments include non-hormonal vaginal moisturizers for VVA symptoms, as well as lubricants to alleviate pain during sexual intercourse. Water-based vaginal moisturizers are available as liquids, gels or ovules and are inserted every few days. Silicone or water-based vaginal lubricants are shorter acting than moisturizers and are applied right before sexual activity.

Postmenopausal women can also opt for low-dose vaginal estrogen preparations in the form of creams, rings or tablets to treat their VVA.

Since none of these options are mentioned in the news release, we give it an Not Satisfactory rating here.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release doesn’t disclose how soon consumers can expect to find Intrarosa at their local drug store. However, it does make clear that DHEA is already out on the market as a dietary supplement, although these have not been FDA approved for safety and efficacy for “diagnosing, curing, mitigating, treating or preventing any disease.”

We feel this mention is good enough for a Satisfactory rating here.

Does the news release establish the true novelty of the approach?

Satisfactory

DHEA is not a new drug. Researchers have also looked at DHEA’s effects on cardiovascular risk, memory and metabolism in older populations. And it’s also sold over-the-counter as a dietary supplement, the news release points out.

But it also states Intrarosa is the first FDA approved product containing prasterone, or DHEA.

Therefore, we give it a Satisfactory rating here.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not use unjustifiable, sensational language. The single quote from the FDA spokesperson also contains neutral, measured language.

Total Score: 4 of 9 Satisfactory

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