http://en.wikinews.org/wiki/Finnish_Infant_Formula_Study_Without_Informed_Consent
Finnish parliamentary ombudsman faults infant formula study

November 2, 2006

Helsinki, Finland – The Finnish Parliamentary Ombudsman has found that
an infant formula study has been conducted on thousands of newborns in
several hospitals without obtaining informed consent from the parents,
who were not informed of the commercial funding for the study.
Additionally, the study was found to have been started and carried out
for six months without ethical committee approval, and suffered from
other shortcomings.

Numerous shortcomings were found in a study which according to
documents signed by WHO Director-General candidate Pekka Puska, head
of the Finnish National Public Health Institute (NPHI) "complies with
the law regarding medical research and good research practice. ...
informed consent fulfills the requirements of the law. ...
distribution of infant formula does not deviate from legal norms."

The Finnish Parliamentary Ombudsman Riitta-Leena Paunio disagreed with
professor Puska. On October 25, the 60th anniversary of the filing of
the indictment in Doctors' Trial (of the Nuremberg Trials) which led
to the framing of modern medical research ethics, she resolved a
complaint filed by The Breastfeeding Support Association in Finland.
According to the resolution, it was not possible for the parents to
give informed consent as required by law due to many reasons.

The Ombudsman lists lack of disclosure of the study's funding, lack of
clear statement pointing the benefits of breastfeeding, lack of
disclosure of the fact that the Principal Investigator working within
NPHI is an inventor and benefactor in a patent on the research formula
owned by the Finnish formula manufacturer Valio, as reasons for lack
of capacity to give informed consent. The Ombudsman also points out
that during discovery of the facts concerning the study, NPHI gave
information which was simply not true. Documents given during
discovery by NPHI were signed by Pekka Puska, the Finnish candidate
for the post of WHO Director-General. NPHI also claimed in statements
signed by professor Puska to have accepted public funding addressed
only directly to it, while in actual fact NPHI accepted public funding
addressed to Valio which Valio directed to NPHI.

Further omissions pointed out by the Ombudsman include lack of the
naming of the one single person responsible for the safety of the
study as required by Finnish law and omissions in giving information
and asking for consent and ethical approval when changes to the study
were made, and the omission of not asking for consent from both
parents.

According to the Parliamentary Ombudsman's resolution, both National
Public Health Insitute and the ethical committee failed in fulfilling
their duties. The Ombudsman reminds that according to the Finnish
Constitution, everyone has the right to life, personal liberty,
integrity and security. No one shall be treated in a manner violating
human dignity. Medical research has a connection to this basic right.
The Ombudsman also cites the Declaration of Helsinki and international
conventions on human rights in her decision. During the discovery
phase of the complaint, the Ministry of Social Affairs and Health
stated that the Declaration of Helsinki, named after the Finnish
capital, is not legally binding.

The aim of the study was to find out whether removal of bovine insulin
from infant formula would reduce type 1 diabetes (IDDM) and find out
mechanisms leading to IDDM, whose prevalence in Finland is more than
in any other country in the world.

The complaint, filed in April, 2004 by The Breastfeeding Support
Association in Finland (founded 1997), asked the Ombudsman to find out
the legality of an infant formula product development study with
national health implications, funded by the Finnish infant formula
manufacturer Valio and carried out by the National Public Health
Institute of Finland.

The two major points in the complaint were to find out

1) whether the study fulfills informed consent requirements, when
parents are not told enough about the benefits of breastfeeding nor
the product development nature and commercial funding of the study

2) whether it is legal to distibute infant formula provided by an
infant formula manufacture free of charge from the hospital with means
which resemble the milk nurse practice of some infant formula
companies.

The Breastfeeding Support Association based the first part of the
complaint on the law concerning medical research. The second part was
based on the part of International Code of Marketing of Breast-milk
Substitutes established in 1981 by the general assembly of the World
Health Organization (WHO) implemented in Finnish law and the United
Nations Convention on the Rights of the Child, (right to best possible
health, advancement of breastfeeding).

The Breastfeeding Support Association pressed that they think the
study's aims (both the product development goals and the scientific
goal of finding out whether dietary bovine insulin triggers the
autoimmune reaction causing IDDM) are valid and important, but that
research should be done according to laws, international conventions
and ethical principles.

While the part of the complaint concerning informed consent was
successful, the Breastfeeding Support Association expressed
disappointment that the part regarding formula distribution was not
successful. The Parliamentary Ombudsman's resolution stated that the
Finnish legislation placing restrictions on gratis infant formula
distribution is not meant to apply to medical research, and the same
holds for food safety legislation. The Breastfeeding Support
Association is looking into whether international conventions require
changes to legislation. The Breastfeeding Support Association has
stated that many of the problems in the study could perhaps have been
avoided if infant formula research would have at least the same checks
and balances as drug research has. This would be prudent, since infant
formula is the only nutrition for most infants in an important phase
of their lives and thus it's effects can be much greater than the
effect of many drugs used only occasionally.

The Breastfeeding Support Association has been concerned with outside,
partly commercial funding directing the research of NPHI. According to
"Good Research Practic, Handbook" (2005), outside funding amounts to
40 percent of NPHI's spending, and the policy is to get as much
outside funding to carry out NPHI's plan of action as possible.
Research on breastmilk was planned in the study the complaint was
filed on, but was not carried out because of lack of funding.

The director of National Public Health Institute of Finland is a
candidate for the Director-General post of the World Health
Organization (election to be held 6th-9th November, 2006), and
considered to be among the three leading candidates by The Lancet.

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