An injectable drug, brexanolone, showed some effectiveness in treating postpartum depression in two phase 3 double-blind randomized controlled trials including 247 women from 30 different research centers, according to research led by the University of North Carolina. Their research showed reductions in reported depression symptoms among study volunteers receiving either the drug or placebo (17 points for those on the drug, compared to a reduction of 12.8 points reduction for those on a placebo).
This study about a potential new drug is important, but the way it is reported leaves holes for the reader. The research was funded by the drug maker, Sage Therapeutics, and the two researchers quoted in the release have financial links to the drug manufacturer. The release should have given us more context about the amount of improvement, and been straightforward about the conflicts of interest.
The American Psychological Association estimates that up to one-in-seven women in the US suffer from some form of postpartum depression, and this disorder can linger for some of them and interfere with their bonding with their child. Existing treatments, such as talk therapy and antidepressants are not always successful and may take weeks to improve the situation.
If approved by the FDA, the drug could be an advance in the treatment of postpartum depression which is common and sometimes serious.
The news release does not mention costs. While a new therapy may not have an established price, the release could have stated “no price is available for this drug.” What would be even better is some context for what women suffering from postpartum pay typically for counseling and medications.
The release notes that there was a reduction in depressive symptoms of 17 points for those on the drug, and 12.8 for those in the placebo group based on the Hamilton Depression Rating Scale. The absolute reduction in the rating scale is given for each group. This information would have been much more helpful if the release also clarified the magnitude of the scale and whether a 4.2-point difference is clinically meaningful.
The release contains one somewhat vague sentence on harms.
The most common (≥10% of subjects) adverse events following during brexanolone injection administration were headache, dizziness and somnolence.
Readers would also be interested in details on whether the drug is safe for nursing infants. That’s not mentioned.
The double-blinded randomized trials are described in detail and readers are able to judge the quality of the evidence. The published study includes an important limitation of the research that’s not mentioned in the release: The trials assessed women for only 30 days; the effects of the treatment beyond 30 days are “unknown.”
There is no disease mongering. The release explains how common postpartum depression is worldwide.
The release notes that Sage Therapeutics funded the research.
Sage Therapeutics is the developer of brexanolone injection and sponsor of the trials. A New Drug Application is currently under review by the FDA and brexanolone injection has been granted Breakthrough Therapy Designation. The FDA has assigned a Prescription Drug User Fee Act target date of December 19, 2018.
What the release doesn’t tell us is that both quoted researchers disclosed financial ties with Sage Therapeutics. This information was included in the studies published in the Lancet.
SM-B reports personal fees from MedScape and grants from Sage Therapeutics, awarded to the University of North Carolina … DRR reports personal fees and has stock options in Sage Therapeutics….
The release mentions that women currently can receive antidepressants for postpartum depression, but that the new drug being studied goes to work relieving symptoms faster than traditional antidepressants — days rather than weeks.
The release notes that the drug is currently under FDA review, with a decision on its approval expected by the end of the year.
The release notes that the new drug would be a novel treatment for postpartum depression, if approved.
There is no unjustifiable language.
Systematic, Criteria-Driven
Do you write news releases?
And want help?
We offer free pre-publication review of releases. SEE MORE →
We will not display your name or e-mail address on the site, nor will we share your e-mail address with any third parties.
Thank you for joining the HealthNewsReview.org mailing list. It’s a good way for you to stay up-to-date on what we’ve published, even if you forget to come to our website every day or every week.
-Gary Schwitzer, Publisher, HealthNewsReview.org
By submitting this form, you are granting: HealthNewsReview.org, University of Minnesota , Minneapolis, MN, 55455, United States, https://www.healthnewsreview.org permission to email you. You may unsubscribe via the link found at the bottom of every email. Emails are serviced by Mailchimp. (See their Email Privacy Policy for details.)
I liked a @YouTube video https://t.co/UK2YPzEodd Steve's Deep Brain
Newsweek story on Zika vaccine to zap brain cancer is fascinating–but needed more caution about mouse research https://t.co/1kK1rs1UM5
Comments
We Welcome Comments. But please note: We will delete comments left by anyone who doesn’t leave an actual first and last name and an actual email address.
We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like