Archived Comments for:
Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent
Recombinant prolactin: A galactagogue or a nutraceutical?
Valerie McClain, n/a
27 July 2007
Does this paper show that recombinant human prolactin is a viable option as a short-term galactagogue? The author's conclude that it is a viable option with few side effects. Yet it seems to me rather premature to assume the safety of recombinant prolactin based on a study where only 9 women received the recombinant.
None of the women were lactating and the study only addressed side effects during the 7 days of administering the drug. Oddly, the placebo group seemed to suffer from more side effects than those receiving the recombinant. How can safety be presumed, when the study used only non-lactating women? More importantly, there is no safety data on infants and possible side effects. How can we consider a short-term course of recombinant prolactin a viable option without knowing how this drug effects lactating women and babies?
The authors list infrequent feeding as one of the causes of lactation insufficiency. Is it the authors' belief that infrequent feeding will be remedied by administering recombinant prolactin? Infrequent feeding is often caused by iatrogenic factors or by uninformed parents who do not understand the need for frequent feeding of infants. These situations can be remedied by increased nursing without the risk of medication. Expanding the reasons for usage of a medication will benefit the drug company but it holds little benefit for those who must pay for it and in some instances risk adverse reactions.
This study was funded by Genzyme who has a proprietary interest in recombinant prolactin. Genzyme owns a patent called "Transgenically produced prolactin." (1) This company considers prolactin a nutraceutical. Nutraceuticals are "nutritional supplements that have dietary and health benefits." (2) Nutraceuticals are part of the fortification industry. Prolactin besides stimulating milk production is also considered by some researchers to stimulate the immune system. Genzyme's patent states that "infant feeding formulas which include transgenic prolactin,e.g., non-glycosylated prolactin of the invention are particularly useful." (3)
The research on DHA in the 1990's started out in a similiar vein. A component in human milk is studied and considered useful with great benefits. These novel components made in imitation of human milk components are marketed and sold to the infant formula and fortification industries. The studies are funded by the industries that stand to gain by the selling of these products. Safety studies funded by the very industries that stand to profit from this research are questionable.
1. US Patent & Trademark Office, patent # 6545198 July 25, 2007 <http://www.uspto.gov/patft/index.html>
2. Genzyme Transgenics Advanced "Nurtaceutical"[Nutraceutical]Program with Production of Human Prolactin July 25, 2007
3. US Patent & Trademark Office, patent # 6545198 July 25, 2007 <http://www.uspto.gov/patft/index.html>
Competing interests
none
Recombinant Human Prolactin
Corrine Welt, Massachusetts General Hospital
29 July 2007
We thank Ms. McClain for her comments and would like to address her concerns. The current study is the first to examine the biological effect of r-hPRL on the breast. We chose not to study lactating women in the pilot studies because establishing the biological activity of r-hPRL would be difficult in already lactating women. As discussed, it would also be difficult to examine changes in bone markers specific to r-hPRL in lactating women because of the enormous changes in bone turnover and the hypoestrogenic state that accompany lactation. R-hPRL stimulation of galactorrhea and the side effect profile suggest that “r-hPRL may be a viable option for short-term lactation augmentation.“ We agree that further studies are necessary in lactating women and as stated in the Conclusions studies are ongoing to examine short and long-term use of r-hPRL in lactating mothers and their infants. These studies are being performed under an investigator sponsored Investigational New Drug (IND) protocol to the United Stated Food and Drug Administration (FDA). R-hPRL is not considered a nutraceutical for purposes of human administration. Regarding the press release from 1997, I am not aware of any development of r-hPRL for infant formula.
These r-hPRL studies are investigator-initiated. The authors designed and carried out all studies and analyzed data. No party from Genzyme Corporation was involved in the study initiation, development, patient recruitment, patient visits, data analysis or manuscript preparation. Genzyme Corporation provided the recombinant human prolactin. The studies are funded by the March of Dimes and the U.S. Food and Drug Administration. A small sponsored research grant from Genzyme Corporation was used at our discretion for subject expenses related to the investigator-initiated study and not covered by the foundation and federal funding.
The indications for medication that can increase prolactin levels are not clearly defined. As we stated in the Introduction, there are a subset of mothers with insufficient prolactin secretion and poor milk production who might benefit from medications that raise prolactin. In the case of Sheehan’s syndrome, previous pituitary surgery or irradiation and congenital prolactin deficiency from Pit-1 or Prop-1 mutations, lactotrophs are absent and the only option for lactation induction would be prolactin replacement. For patients in which it is not an option to increase feeding frequency to maintain the milk supply, i.e. when the mother is critically ill or the infant is unable to suckle and frequent breast pumping is unable to sufficiently stimulate milk production, agents that increase prolactin may be able to facilitate relactation at a later stage.
We all strive to manage breastfeeding with as few medical interventions as possible. However, when the medical or circumstantial situation makes normal lactation impossible, a safe and FDA approved treatment option is needed in the Unites States where no such medication is available. Defining the indications for r-hPRL and its safety profile are our ultimate goal.
Competing interests
Genzyme Corporation provided a sponsored research grant for this work.
International Breastfeeding Journal
Recombinant prolactin: A galactagogue or a nutraceutical?
27 July 2007
Does this paper show that recombinant human prolactin is a viable option as a short-term galactagogue? The author's conclude that it is a viable option with few side effects. Yet it seems to me rather premature to assume the safety of recombinant prolactin based on a study where only 9 women received the recombinant.
None of the women were lactating and the study only addressed side effects during the 7 days of administering the drug. Oddly, the placebo group seemed to suffer from more side effects than those receiving the recombinant. How can safety be presumed, when the study used only non-lactating women? More importantly, there is no safety data on infants and possible side effects. How can we consider a short-term course of recombinant prolactin a viable option without knowing how this drug effects lactating women and babies?
The authors list infrequent feeding as one of the causes of lactation insufficiency. Is it the authors' belief that infrequent feeding will be remedied by administering recombinant prolactin? Infrequent feeding is often caused by iatrogenic factors or by uninformed parents who do not understand the need for frequent feeding of infants. These situations can be remedied by increased nursing without the risk of medication. Expanding the reasons for usage of a medication will benefit the drug company but it holds little benefit for those who must pay for it and in some instances risk adverse reactions.
This study was funded by Genzyme who has a proprietary interest in recombinant prolactin. Genzyme owns a patent called "Transgenically produced prolactin." (1) This company considers prolactin a nutraceutical. Nutraceuticals are "nutritional supplements that have dietary and health benefits." (2) Nutraceuticals are part of the fortification industry. Prolactin besides stimulating milk production is also considered by some researchers to stimulate the immune system. Genzyme's patent states that "infant feeding formulas which include transgenic prolactin,e.g., non-glycosylated prolactin of the invention are particularly useful." (3)
The research on DHA in the 1990's started out in a similiar vein. A component in human milk is studied and considered useful with great benefits. These novel components made in imitation of human milk components are marketed and sold to the infant formula and fortification industries. The studies are funded by the industries that stand to gain by the selling of these products. Safety studies funded by the very industries that stand to profit from this research are questionable.
1. US Patent & Trademark Office, patent # 6545198 July 25, 2007 <http://www.uspto.gov/patft/index.html>
2. Genzyme Transgenics Advanced "Nurtaceutical"[Nutraceutical]Program with Production of Human Prolactin July 25, 2007
<http://http://www.transgenics.com/pressreleases/pr110697.html>
3. US Patent & Trademark Office, patent # 6545198 July 25, 2007 <http://www.uspto.gov/patft/index.html>
Competing interests
none
Recombinant Human Prolactin
29 July 2007
We thank Ms. McClain for her comments and would like to address her concerns. The current study is the first to examine the biological effect of r-hPRL on the breast. We chose not to study lactating women in the pilot studies because establishing the biological activity of r-hPRL would be difficult in already lactating women. As discussed, it would also be difficult to examine changes in bone markers specific to r-hPRL in lactating women because of the enormous changes in bone turnover and the hypoestrogenic state that accompany lactation. R-hPRL stimulation of galactorrhea and the side effect profile suggest that “r-hPRL may be a viable option for short-term lactation augmentation.“ We agree that further studies are necessary in lactating women and as stated in the Conclusions studies are ongoing to examine short and long-term use of r-hPRL in lactating mothers and their infants. These studies are being performed under an investigator sponsored Investigational New Drug (IND) protocol to the United Stated Food and Drug Administration (FDA). R-hPRL is not considered a nutraceutical for purposes of human administration. Regarding the press release from 1997, I am not aware of any development of r-hPRL for infant formula.
These r-hPRL studies are investigator-initiated. The authors designed and carried out all studies and analyzed data. No party from Genzyme Corporation was involved in the study initiation, development, patient recruitment, patient visits, data analysis or manuscript preparation. Genzyme Corporation provided the recombinant human prolactin. The studies are funded by the March of Dimes and the U.S. Food and Drug Administration. A small sponsored research grant from Genzyme Corporation was used at our discretion for subject expenses related to the investigator-initiated study and not covered by the foundation and federal funding.
The indications for medication that can increase prolactin levels are not clearly defined. As we stated in the Introduction, there are a subset of mothers with insufficient prolactin secretion and poor milk production who might benefit from medications that raise prolactin. In the case of Sheehan’s syndrome, previous pituitary surgery or irradiation and congenital prolactin deficiency from Pit-1 or Prop-1 mutations, lactotrophs are absent and the only option for lactation induction would be prolactin replacement. For patients in which it is not an option to increase feeding frequency to maintain the milk supply, i.e. when the mother is critically ill or the infant is unable to suckle and frequent breast pumping is unable to sufficiently stimulate milk production, agents that increase prolactin may be able to facilitate relactation at a later stage.
We all strive to manage breastfeeding with as few medical interventions as possible. However, when the medical or circumstantial situation makes normal lactation impossible, a safe and FDA approved treatment option is needed in the Unites States where no such medication is available. Defining the indications for r-hPRL and its safety profile are our ultimate goal.
Competing interests
Genzyme Corporation provided a sponsored research grant for this work.