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No one is going to sign their infant up for that double blind study. PPD can be life or death, so it’s up to the provider to choose the risk to the mother vs. the risk to the infant. I don’t think there are any easy answers there
It would also be a violation of HHS regulations for pediatric research which clearly state the research must be of minimal risk, not unknown, or present direct benefit to the children which this does not.
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...
> ... simply stop breastfeeding while taking the medication. I wonder if doctors recommend that for this or other drugs?
Yes, all the time. It was part of the study protocol too.
> I'd hope they inform the mother at the very least.
It's in both the patient and physician handouts to discuss the risks/benefits and alternatives. Formula is available as are breast milk donations in certain regions.
This is neither the first nor last medication that may be excreted in breastmilk we have to deal with in medicine and there are systems and processes in place to address these situations.
Hopefully some data is compiled in the next years on the actual safety for infants.
"The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition."
"More" data is always better, nobody disagrees. But more data costs more and takes more time to gather. So the trade off is - do we approve this medicine now, knowing what the risk are, are do we not and deny patients this medicine?
There is no "safe" drug. There is no drug where all the risks are known. Even the FDA will tell you that. It's all a risk-benefit trade off.
Is the FDA immune from suits if this results in a generation of damaged kids? Was it so hard to say "oh..... It ends up in breast milk. We should compare the kids"? Even if it defers the approval by some years?
And there is nothing wrong or negligent about “solving this with a pill.” It needs solving. It is a serious issue.
There are much cheaper treatments for PPD, but nothing that would ever pay for the approval process.
https://twitter.com/jamesknochel/status/1688023798447316992?...
Your points are well made, though this isn't really what I said.
For what it's worth, while I'm worried the decision was made on what essentially amounts to an assumption, the option for using formula exists for parents worried about the drug making it into breast milk. So it seems there's at least one mitigating factor. But it wouldn't surprise me if the drug ends up being labeled for leeching into breast milk later on.
Is this based on any experience (clinical or research) in postpartum depression or some philosophical objection?
In case you were unaware of what severe postpartum depression can look like:
Severely ill patients often report suicidal ideation and behavior, typically demonstrate obvious impairment of functioning, and often manifest poor judgement that places the patient and others (including children) at risk for imminent harm. In addition, patients are more likely to develop complications such as psychotic and catatonic features and have a history of severe or recurrent episodes. Patients with severe major depression should be referred to a psychiatrist for management and often require hospitalization.
Source: UpToDate
> Is the FDA immune from suits if this results in a generation of damaged kids?
Sued for what? It's clearly stated in the drug monograph.
Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk (see Data). There are no data on the effects of zuranolone on a breastfed infant and limited data on the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZURZUVAE and any potential adverse effects on the breastfed child from ZURZUVAE or from the underlying maternal condition.
https://documents.sage-biogen.com/us/zurzuvae/pi.pdf
> We should compare the kids"?
All patients enrolled in the trial were asked to stop breastfeeding. It is unethical to perform the study you are suggesting and even if it were no IRB would approve per regulations.
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...
For drugs approved between 2000 and 2010 (for all 3 agencies, the FDA gets more applications) the FDA approval time was a median of 268 days, faster than the EMA at 356 days and Health Canada at 366 days.[2]
Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?
http://www.slate.com/articles/health_and_science/medical_exa...
It's still true, we still don't have them. Obama even passed a law about it and it didn't help.
> Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?
This is obviously true. Are Americans, Canadians and Europeans all different species? No. Are all three countries slash political unions capable of running clinical trials? Yes. Do the FDA or Health Canada trust each other enough to allow things the other approved? No.
Although the FDA is sometimes surprisingly relaxed - here's a nootropics company selling drinks with at least two unapproved medications in them, adrafinil and omberacetam: https://www.trubrain.com/products/drinks.
Once again, source?
> This is obviously true.
As you only mentioned the FDA, and keep only mentioning the FDA, it is not obviously true that you are arguing against all Western drug approval agencies and not specifically the FDA.
> Are Americans, Canadians and Europeans all different species?
All being the same species does not mean all have the same regulatory framework and in fact they don't. I am sorry but I really don't understand any of the points you're trying to make.
Not having sunscreen harms people by giving them skin cancer.
> As you only mentioned the FDA, and keep only mentioning the FDA, it is not obviously true that you are arguing against all Western drug approval agencies and not specifically the FDA.
I didn't say anything about them in my original post so I'm certainly open to believing they're also too slow.
Europeans certainly seem to believe a lot of strange things about American food that are just protectionism from their farmers.
> All being the same species does not mean all have the same regulatory framework and in fact they don't. I am sorry but I really don't understand any of the points you're trying to make.
Yeah but that's bad. It's also eg bad that every American city has completely different housing regulations.
My only question to you is this, you said:
"The FDA mostly harms the population by not approving drugs fast enough."
Do you have a source that says on the whole the FDA harms more people by not approving drugs more quickly, MORE than any safety added by this process.
Please note this would mean a citation that has looked at MANY approvals and timelines while ALSO looking at rejections for potential harm and concluding that the process is more harmful than beneficial.
To explain to you why yours is insufficient, even if we accept that this ONE example has caused harms you have not addressed any potential safety issues that have been prevented in OTHER therapeutics by the long process, this may in fact be zero or less than the harms caused by delays but requires evaluation in order to draw the conclusion you are making.