Parliamentary Ombudsman: Finnish Infant Formula Study without Informed Consent

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Parliamentary Ombudsman: Finnish Infant Formula Study without Informed

Consent

 

(Helsinki, Finland, November 2, 2006)

 

Parliamentary Ombudsman: FINNISH infant formula study on newborns

without informed consent - commercial funding of the study was not

disclosed to parents, study started and went on for six months without

ethical committee approval, many other shortcomings 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

Mr. 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 Ombusman 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 Mr. 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.

 

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 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

successfull, it was a disappointment to The Breastfeeding Support

Association that the part regarding formula distribution was not. 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-8th November, 2006), and

considered to be among the three leading candidates by The Lancet.

 

 

Background

 

 

The Breastfeeding Support Association in Finland

 

The Breastfeeding Support Association in Finland is a volunteer based

association, founded in 1997. The foundation for the work of

association is the United Nations Convention on the Rights of the

Child (article 24) and WHO breastfeeding promotion programs.

 

The Association is funded by membership fees, advertisements in the

Imetysuutiset newsletter and fees on training of volunteers. The local

support groups are financially independent. RAY (Finland's Slot

Machine Association which funds health and social welfare projects)

has awarded the association a grant for 2005/06 for the purpose of

establishing a nationwide project, which includes the maintenance and

advertising of the Breastfeeding Support Hotline.

 

The City of Helsinki has awarded the Association a small grant

annually to support mothers in the Helsinki area. In the other

municipalities in Finland some local groups have had opportunities to

apply for grants from local social authorities.

 

 

Functions of the Parlimentary Ombudsman

 

From The Parliamentary Ombudsman's web site:

 

" The Ombudsman exercises oversight to ensure that public authorities

and officials observe the law and fulfil their du­ties in the

discharge of their functions. In addition to authorities and

officials, the scope of oversight includes also other parties

performing public functions.

 

The aim is to ensure good administration and the observance of

constitutional and human rights. "

 

 

 

Source:

 

http://en.wikinews.org/wiki/Finnish_Infant_Formula_Study_Without_Informed_Consen\

t

 

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The Breastfeeding Support Association in Finland: Summary of the

Complaint

 

 

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 @ 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 development

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).

 

Need to contact someone in the Association? Send an email to itu @

imetys.fi

 

Source: http://www.imetys.fi/itu/english/findiasummary.htm