I was going to write a short post about my presentation at the meeting of the Canadian Association of Pediatric Health Centers (CAPHC) in Quebec city. I was asked by the organizers to talk about how variations in practice affect patient safety. So I put together what I think was a great panel, with myself, Sophie Gravel, our NICU co-ordinator also a mother of a preterm infant and a breast-feeding advocate, and Barbara Farlow, an active member of Patient Safety Canada and a mother of a girl (who had trisomy 13) who died in hospital at a few weeks of age.
I think the panel went well, we had a good attendance and good comments, and I certainly learned a great deal from my co-presenters. The symposium was sponsored by Mallinckrodt, who are now the company responsible for selling and marketing inhaled NO. Which is not the subject I am referring to in the title of this post. Mallinckrodt had no input into the subject of the symposium, or its content, and I did not mention nitric oxide in my talk (even though use of iNO in the preterm is great example of what I was discussing, variations in practice!) It was, I think a good example of a non-directed educational contribution from a pharmaceutical/medical supplies company. (Even though I still feel uncomfortable accepting my expenses and honorarium from “pharma”. My honorarium will be donated to my research funds).
What stunned and outraged me was what I found in the materials I received when I registered for the meeting.
At noon today there is a talk on using exclusive human milk feeds for preterm infants, sponsored by the only company who supplies human milk-based formula and fortifier for preterm infants.
This is outrageous.
CAPHC should be ashamed.
This breaks all the rules that they should be abiding by,
It is an immoral sell-out.
The organisation, which has a mission “to improve health service delivery for Canadian children and youth”, has sold out so that its members can get a free lunch.
Alan Lucas, whose research has been important in improving care of preterm infants, has been flown in from London to give some sort of credibility for this symposium. Apparently he is going to discuss the proven benefits of an exclusive human milk based diet in preterm infants. Which should take him about 3 minutes.
To recap, for those who have not been memorizing my blog posts for the last few years.
Prolacta, for it is they of whom I speak, have sponsored 2 trials in preterm infants (500 to 1250 g birth weight). One modestly sized study of infants whose mothers were planning to breast feed (n=207), another very small trial for infants whose mothers could not or did not plan to (n=53). The studies were registered as a single trial, but reported as 2 trials (which I think is OK for these trials, there was no real overlap either in the interventions or in the patients) the trial in formula fed babies was blinded, the other was not. The primary outcome for the trials was duration of Parenteral Nutrition: the formula trial showed a reduction in TPN duration, the other did not. The initial study reports show trials that are pretty reasonable quality, apart from the very small size of the formula trial. Unfortunately there have been 3 publications of post-hoc secondary analyses of the trials, as the company try to squeeze more significant data from the results.
Prolacta make a great deal out of the fact that the rate of NEC in the control groups in the 2 studies was very high (21% in the formula trial controls, 16% in the breast fed trial controls, who got cows’ milk based fortifier or cows’ milk based formula if they ran out of mother’s milk).
That isn’t of course how the company promotes their milk. They promote it as showing a significant reduction in NEC. In fact if you do the statistics yourself, the trial that was entitled “An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis….” actually shows a difference in NEC (which was a secondary outcome and should not have been in the title) which is only significant if you put the 2 human milk groups together.
As I said, before I got a bit side-tracked, discussing the results of the one (or maybe two) trials should not take Dr Lucas very long. If Dr Lucas was a Canadian Physician he would in fact be in breach of the CMA guidelines which clearly state the following:
Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA’s Code of Ethics, which prohibits endorsement of a specific product.
CAPHC you should be ashamed. You must also change your practices, we can have no respect for an organization prepared to allow this sort of seminar as part of its meetings.
Neonatal Research 