The Summary of The Complaint

The Breastfeeding Support Association in Finland: Complaint concerning an infant formula study

The Breastfeeding Support Association in Finland (Imetyksen tuki ry, http://www.imetys.fi/itu/english/) has filed a complaint to the Parliamentary Ombudsman (http://www.oikeusasiamies.fi/Resource.phx/eoa/english/index.htx) concerning a medical intervention study with infant formula, funded by an infant formula manufacturer. The study is represented to the parents as research into the causes of type 1 diabetes, but the company funding the research has received product development funding for the study. The complaint names the officials responsible for the planning and supervision of the study which aims to find whether there's a causal link between insulin-dependent diabetes mellitus (type 1 diabetes) and exposure to bovine insulin in genetically at-risk infants, and whether type 1 diabetes in genetically at-risk infants can be prevented by removing bovine insulin from infant formula. The study was carried out within the framework of the Finnish National Public Health Institute (http://www.ktl.fi/portal/english/) and was funded by an infant formula manufacturer, and the officials include the ethical review board (institutional review board/independent ethics committee), the primary person responsibly for the study according to Finnish law, and the personnel at National Public Health Institute and hospitals with duties regarding the research. The complaint was filed in April 2004, and is available at http://www.imetys.fi/itu/kantelu/ (in Finnish). For inquiries email: itu (at) imetys.fi

What led to the complaint concerning the study?

The Breastfeeding Support Association in Finland was told that in the Kätilöopisto Maternity Hospital in Helsinki, baby formula was going to be be distributed free of charge to thousands of newborns. This plan sounded like "milk nurses" hired by infant formula companies, because it takes advantage of mothers' trust for public healthcare and can lead mothers to believe that formula is better than mother's milk. We tried to find if an independent review of the distribution practices of the formula had been done. We didn't find anyone who had done so, and supervision of the study seemed like it was very careless. This lead us to suspect that similar problems can also exist in other studies.

What were the main points in The Breastfeeding Support Association's complaint?

The main points of the complaint were: 1) lack of informed consent, because not enough information about the study was available and 2) distribution of infant formula free of charge out of the hospital

Why was the consent not informed?

The Breastfeeding Support Association in Finland (Imetyksen tuki ry) considered the information insufficient because a) the benefits and risks were not sufficiently discussed, b) the funding and organizations behind the research were not sufficiently disclosed, c) the person in charge of the study as required by Finnish law was not mentioned in the information. The Helsinki Declaration of the World Medical Association requires funding to be disclosed, also National Public Health Institute's internal instructions require the principles of the Helsinki Declaration to be followed.

What else was found out when the complaint progressed?

The research has started and progressed ca. six months without the ethical review board's supportive statement (required by law). The study seems to be funded exclusively by the infant formula manufacturer. The person named as the leader of the study is a benefactor in a patent covering the manufacture of the research formula. The patent is owner by the infant formula manufacturer. Tissue samples have been taken without proper written consent as required by law. Samples have been used in other studies without proper informed consent. Research has been carried out on the samples which differs from the consent obtained. The law requires the ethical review board gives a statement, with arguments provided on the ethical aspects of a study ("perusteltu lausunto" in Finnish). In practice the statement appears to consist of one or two words with no justifications and no arguments provided. In media, anothe National Public Health Institute diabetes study came up, where there was good scientific practice and dishonesty ("vilppi" in Finnish).

Why does The Breastfeeding Support Association concern itself with medical studies?

Medical research is connected to our activity when it's reminiscent of infant formula marketing. On the other hand, when the complaint has progressed, the issue of the effect of private money on the direction of breastmilk and infant formula has surfaced. Research was also planned to studu breastmilk, but due to lack of funding this research was not carried out. The policy of National Public Health Institute is to get "as much outside funding as possible" for research. This directs research to commercially viable purposes like infant formula product development, and away from research on the effects of breastfeeding. Part of the issues which came into light during the complaint process - like questions about the leadership of the research or transparency of the action of the ethical review board - are not directly connected to breastfeeding or infant formula, but we considered it our duty to bring also these issues into the light when we noticed them.

Is it legal to distribute infant formula out of the hospital?

It is permitted for hospitals to distibute formula donated by industry under certain conditions. Giving infant formula is permitted only to infants who need it, and the donor must give formula the whole time the infant needs it. According to Finnish recommendations, the infant needs formula until she is one year old, unless she's breastfed. A breastfed child does not necessarily need formula at all.

What's wrong with distributing formula out of the hospital?

There are rules about the distribution of infant formula to encourage breastfeeding. Distributing infant formula free of charge may lead to formula use when not really necessary. Use of infant formula can make breastfeeding harder. The rules have been written to secure the possibility for breastfeeding.

Shouldn't there be studies like this?

We consider the aims of the study - both aims, the product developmend and inquiry into the development of type 1 diabetes - good and important. However, studies must be carried out inside the bounds of the law and in a way which can tolerate ethical appraisal. The families have a right to know the funding and aims of the research, and the research should be carried out carefully and according to the protocols. We consider it very alarming how poorly the study concerning many infants' only nutrition has been supervised, implemented and controlled.

What conventions and laws was the complaint based on?

The complaint is based, among others, on the United Nations Convention on the Rights of the Child, (right to best possible health, advancement of breastfeeding), the United Nations International Covenant on Civil and Political Rights (consent for medical experiments), International Code of Marketing of Breast-milk Substitutes (WHO 1981, infant formula distribution), law regarding medical use of human tissues (kudoslaki, use of tissue samples for purposes other than what the consent is acquired for), law regarding medical resarch (tutkimuslaki, several issues), potilaslaki (information about treatments), law regarding National Public Health Institute (laki Kansanterveyslaitoksesta, privately funded research) and the European Council convntion on bioethics (informed consent). The World Medical Association's Helsinki Declaration defines, what informed consent means (and is referred to in the works of the law regarding medical research).