"How many more years do you estimate will pass before pharmaceutical companies will fully acknowledge the available science in regard to the pharmacokinetics of drugs in human milk?"
It is actually happening right now with the new FDA lactation labelling requirements for all new drugs and eventually for current drugs. The blame does not really lie with the pharmaceutical companies. They most probably have always had the data, but the current labelling requirements do not allow the companies to put this data in the package insert without accepting any liability, because if they are included, and then a breastfeeding child suffers any possible side effects, the pharmaceutical company will be sued because it included data in the labelling that the FDA did not authorize. Once the new labelling requirements are included in the packaging insert, the pharmaceutical company can include the pharmacokinetics in the labelling and not suffer any liability because they have used acceptable labelling. Granted, it will still take a while before the new labeling requirements kick in, but it will happen.
" The cognitive inertia of drug manufacturers who ignorantly and stubbornly insist on using placental transfer as their only frame of reference during pregnancy and all of lactation is irresponsible and dangerous."
As I have stated, the drug manufacturers, in reality, are stubbornly following the FDA regulations, so they do not get their pants sued off. As for pregnancy, the FDA and NIH are finally working with the drug companies to try to get data during pregnancy, which is not all that easy. No one wants to harm a pregnant woman and her baby testing drugs.
"I do not wish to speak for others, but I suspect that many of us in the field possess a chronic weariness of what appears to be willful neglect of this science by the pharmaceutical industry. It surely isn't benign neglect."
There is indeed a chronic weariness but is it due (entirely, at least) to the pharmaceutical industry? For example, how hard did the breastfeeding community fight all this time to change the labelling requirements so this data could be used? Why did it take our taxpayer funded FDA so long to finally make the change? How many physicians and pharmacists remain ignorant of all the excellent pharmacokinetic data in the public venue (just see what Tom Hale and I have out there)? Indeed, it surely isn't just benign neglect. The real question to be asked is whose neglect is it?
The pharmaceutical industry certainly considers the bottom line as most of us do. Some do worse than that, but most do a rather decent job of making our lives better, safer, and definitely longer than before the pharmaceutical industry existed, including for breastfed babies. Actually, allowing the companies to put their scientific data in the labelling will help their bottom lines also because more women will now be able to take medications while breastfeeding based on pharmacokinetic data.
Frank J. Nice, RPh, DPA, CPHP
________________________________
From: Debra Swank <[log in to unmask]>
Sent: Friday, November 13, 2020 12:05 AM
To: [log in to unmask] <[log in to unmask]>; Frank J Nice, Pharmacist <[log in to unmask]>
Cc: Debra Swank <[log in to unmask]>
Subject: A hypothetical question for Drs. Nice & Hale and others in pharmacology
A hypothetical question for Drs. Frank Nice and Tom Hale and your compatriots in pharmacology:
How many more years do you estimate will pass before pharmaceutical companies will fully acknowledge the available science in regard to the pharmacokinetics of drugs in human milk? The cognitive inertia of drug manufacturers who ignorantly and stubbornly insist on using placental transfer as their only frame of reference during pregnancy and all of lactation is irresponsible and dangerous.
I do not wish to speak for others, but I suspect that many of us in the field possess a chronic weariness of what appears to be willful neglect of this science by the pharmaceutical industry. It surely isn't benign neglect.
With gratitude for your work,
Debbie
Debra Swank, RN BSN IBCLC
Program Director
MoreThanReflexes Education
Elkins, West Virginia USA
http://www.MoreThanReflexes.org
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