Tuesday

The PROBIT studies by Michael S. Kramer



Anyone else been following Lactnet and the Michael Kramer thread? Me, me, me, me......I even sent an email to the Lactnet listmothers, asking them if they would consider my comments worthy of sharing with Lactnet subscribers...NOT. Of course, I think my comments might further clarify the PROBIT (Promotion of Breastfeeding Intervention Trial) studies. But clarity and other viewpoints seem to be illusive in our world. I wrote the following email to Lactnet.

from the email:
Dear Lactnet Listmothers:
I have been following the thread on Lactnet regarding Canadian researcher, Michael S. Kramer and was hopeful that my comments were worth sharing with Lactnet subscribers. The PROBIT study by Michael S. Kramer et al. was published in JAMA in 2001. It showed a very positive view of breastfeeding and particularly showed that with positive breastfeeding interventions, more women would breastfeed longer and exclusively. (WHO defintion of exclusive breastfeeding). And it seemed to show the positive health benefits to infants when mothers exclusively breastfeed. In the 2001 JAMA paper it stated that "Atopic eczema was reduced by 46%." This paper stated, "In addition the prevalence of exclusive breastfeeding was seven fold higher in the experimental group [interventions to encourage exclusive breastfeeding and longer duration of breastfeeding] at 3 months (43.3% vs. 6.4%) although low in both groups at 6 months (7.9% vs 0.06%)." Looking at the data, the prevalent mode of feeding was MIXED FEEDING not exclusive breastfeeding. Health benefits to infants were visible despite the fact that a majority of infants were not exclusively breastfed.
http://jama.ama-assn.org/cgi/content/full/285/4/413

In 2007, the BMJ published another sudy using PROBIT participants who were now children, again lead by researcher Michael Kramer entitled, "Effect of prolonged & exclusive breastfeeding on risk of allergy & asthma..." This study shows no benefit of lengthy or exclusive breastfeeding regarding allergy or asthma. They used skin prick tests (for dust mites, cat, birth pollen, mixed northern grasses, and Alternaria) on the children. The majority of PROBIT infants were not exclusively breastfeed. How do we come to a clear understanding of the relationship between how one is fed as infant and health effects, if one is fed not only breastmilk but other milks?
http://www.bmj.com/cgi/content/full/335/7624/815

Of interest regarding the BMJ paper, is that the list of authors to this paper are different than the JAMA study. Last author to the BMJ paper is a Bruce Mazer. While he is also a Canadian researcher from McGill University, he also has represented the drug company, Fujisawa Healthcare, inc. see
http://www.wvdhhr.org/bms/sPharmacy/PDL/Mtg_agenda_minutes/bms_pdl_20030122minutes.pdf
Interestingly this drug company sells Protopic Ointment for atopic dermatitis. In 2001 the FDA issued a warning letter to this company for this ointment because their TV ads were determined to be misleading.

The PROBIT study was funded by the Canadian Institute of Health Research (Canadian government). While researchers may do research at the universities or through various government agencies, they also maybe funded by various industries. Does this negate the sicience? Possibly. When I look at studies/papers I look at not only the first author of the study but the last author. Often the last author is of more importance to the study--gathering the funding, guiding the particular research. It looks to me like Mazer in the BMJ study is of importance, particularly when one is refuting the original work of the study in which your data is based.

Should we believe that the 2001 study was defective in regard to allergy and asthma? Does the newer study gave [give] us better science? Or is this paper a reflection of a change in authors? Bruce Mazer is paid by a drug company that specifically markets meds to alleviate atopic dermatitis. How is the drug market effected when we believe that exclusive and lengthy breastfeeding does not impact allergies or asthma? Or how is it impacted when we have one study that says one thing and another the reverse? Confusion...maybe less reason to support breastfeeding, more media stories that say that health effects of breastfeeding are minimal...

It would seem to me that it would be highly improbable that Michael Kramer did not know of Mazer's association with Fujisawa Healthcare Inc. and the drugs designed by this company against allergy. This is something that should have been disclosed before publication. These two studies give us a good view of how changing the author can reverse the original findings. The problem with the original study and this follow-up on allergy and asthma is that one cannot use mixed feeding of infants to determine health effects. One needs to examine exclusive breastfeeding versus exclusive formula feeding to get the real picture. The original paper gave us a real understanding of how positive interventions (BFHI) will increase the duration and exclusivity of breastfeeding. The second paper muddies the waters of our understanding about health effects and breastfeeding because a majority of the infants were not exclusively breastfed.

Sincerely,
Valerie W. McClain, IBCLC"

These further comments were not sent. According to one report read on the internet, "Canada's patent holding pharmaceutical companies have teamed with the CIHR (Canadian Institute of Health Research) to create the not-for-profit R & D Health Research Foundation." PROBIT studies were funded by the CIHR. Do pharmaceutical companies partnered with government give us better studies or more studies supportive of pharmaceutical objectives? The CDC has its own foundation, too, in which the pharmaceutical and infant formula industries support. So how much of science funded by government is a science seeking the truth and how much is science seeking customers? Should we allow our health care professionals to understand how much their "evidence-based" medicine is owned by the pharmaceutical and infant formula industry? Yes, silence wins again.
Copyright 2009 Valerie W. McClain

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