Not to mention the Finns
Part of the old Cole Porter song, Let's Do it (Let's Fall in Love), goes:
The Dutch in old Amsterdam do it
Not to mention the Finns
Folks in Siam do it - think of Siamese twins
The idea being that everybody, everywhere, is doing it. The same goes, it seems, with research ethics abuses. In April 2004, The Breastfeeding Support Association of Finland lodged a complaint with the Finnish Parliamentary Ombudsman about a study led by researchers within the Finnish National Public Health Institute. The study aimed at finding out whether removal of bovine insulin from infant formula would reduce type 1 diabetes (IDDM) and the mechanisms of the condition. The study involved giving infant formula to newborns, and continuing to provide free formula after discharge of mother and child from the hospital.
Sounds good, until you go into the details. The study proceeded for six months before ethics approval was sought. The participants were not told that the study was funded entirely by a Finnish baby formula manufacturer (Valio), or that the principal investigator of the study was an inventor and benefactor of the patent for the formula being given to participants. The participants were not told that they were basically in a product development study for a private company, and worse still, they were not adequately informed about the benefits of breastfeeding as opposed to formula. The free distribution of formula raises additional concerns about undermining the ability of mothers to breastfeed and making mother and child dependent on the research product. The more the Ombudsman dug, the worse it got. Shades of Nestle's infant formula marketing in Africa, though a fair judgment of the case will have to wait until the researchers respond to the Ombudsman's findings.
An interesting twist to the story is that Pekka Puska, head of the Finnish National Health Institute, signed off on the study, claiming that it "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." Mr. Puska is also one of the leading candidates for the position of Head of the World Health Organization, which is planned to be filled by next week. Which means that he still has time to reflect on the differences between the law and ethics, and to brush up on that other Finnish product, the Declaration of Helsinki.
The Dutch in old Amsterdam do it
Not to mention the Finns
Folks in Siam do it - think of Siamese twins
The idea being that everybody, everywhere, is doing it. The same goes, it seems, with research ethics abuses. In April 2004, The Breastfeeding Support Association of Finland lodged a complaint with the Finnish Parliamentary Ombudsman about a study led by researchers within the Finnish National Public Health Institute. The study aimed at finding out whether removal of bovine insulin from infant formula would reduce type 1 diabetes (IDDM) and the mechanisms of the condition. The study involved giving infant formula to newborns, and continuing to provide free formula after discharge of mother and child from the hospital.
Sounds good, until you go into the details. The study proceeded for six months before ethics approval was sought. The participants were not told that the study was funded entirely by a Finnish baby formula manufacturer (Valio), or that the principal investigator of the study was an inventor and benefactor of the patent for the formula being given to participants. The participants were not told that they were basically in a product development study for a private company, and worse still, they were not adequately informed about the benefits of breastfeeding as opposed to formula. The free distribution of formula raises additional concerns about undermining the ability of mothers to breastfeed and making mother and child dependent on the research product. The more the Ombudsman dug, the worse it got. Shades of Nestle's infant formula marketing in Africa, though a fair judgment of the case will have to wait until the researchers respond to the Ombudsman's findings.
An interesting twist to the story is that Pekka Puska, head of the Finnish National Health Institute, signed off on the study, claiming that it "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." Mr. Puska is also one of the leading candidates for the position of Head of the World Health Organization, which is planned to be filled by next week. Which means that he still has time to reflect on the differences between the law and ethics, and to brush up on that other Finnish product, the Declaration of Helsinki.
posted by Stuart Rennie at 11:42 PM
7 Comments:
There's a response from NPHI at
http://www.ktl.fi/portal/suomi/ajankohtaista/?id=976 (in Finnish)
NPHI says they will publish the results from the study (which publications publish studies where informed consent has not been obtained?). With a quick perusing of the statement, it appears the only thing they're willing to admit as a shortcoming is the part about not telling that the PI of the study is a benefactor on a patent owned by the formula manufacturer. They seem to be unwilling to even accept what reads in the resolution of the Ombudsman, instead reporting the resolution as "According to the newspaper, Ombudsman criticizes.." - or maybe the person writing the release hasn't read the Ombudsman's resolution yet.
The Ombudsman's resolution (or actually only selected parts) can be found at
http://www.eduskunta.fi/triphome/bin/thw/trip/?${html}=eoap5000&${APPL}=ereoapaa&${BASE}=ereoapaa&${THWIDS}=0.51/319750&${MAXHITS}=10&${THWURLSAVE}=51/319750
(in Finnish)
Dear Visitor,
Thanks for your comments and links. Can you read Finnish? (I can't.) If you find more information out, you are invited to write a post for this blog, if it interests you.
Stuart
Thanks for the invitation - I can read Finnish, and write it, too! I just wrote a short article on bioetiikka blog - maybe I could write something similar in English? It's worth a look even if you don't read Finnish, as there's a link to quite an interesting article in English wrt Finnish policies and discussion atmosphere on bioethics and medical research. (Re-examining medical modernization - Framing the public in Finnish biomedical research policy).
Here's an attempt to translate the response by NPHI to the newspaper article reporting Ombudsman's resolution, maybe now you can comment also yourself on what you think of NPHI's reaction.
(warning: layman's unofficial translation, I tried to be accurate, may contain errors, original at
http://www.ktl.fi/portal/suomi/ajankohtaista/?id=976)
FinDia study was not done without parent's knowledge
November 6, 2006
Honoring the participants and promoting children's health are the
primary ambition of National Public Health Institute and it's
researchers.
Helsingin Sanomat told in an article (November 4, 2006) about the
Parliamentary Ombudsman's decision on a complaint filed by the
Breastfeeding Support Association in April 2004. The complaint
was about the FinDia study, which is a study to prevent children's
diabetes.
In the article "Infant formula study had several faults" Helsingin
Sanomat told that ombudsman Riitta-Leena Paunio took a position that
"In the study by Valio and NPHI samples were taken without parent's
knowledge." According to the newspaper ombudsman criticizes the
contents of the participant information statement, the unclarity of
consent form and the description of collecting information, which had
omissions on how their confidentiality is guaranteed.
Ombudsman made her decision on October 25, 2006. As her action, she
sent her decision to National Public Health Institute and the ethical
committee of the Hospital District of Northern Savo.
FinDia study
FinDia study is significant study, which has received international
attention and great hopes. The aim is to study the reasons leading to
type 1 diabetes acquired in childhood.
The research tries to find out which part dietary bovine insulin plays
in the onset of type 1 diabetes with a double-blinded trial. Children
with a cord blood sample-measured genetic risk to acquire type 1
diabetes have been called into the study. One group of these children
have been given ordinary cow milk formula, another group has been
given research formula with bovine insulin removed. The third group
has been given formula in which proteins contain in the milk have been
hydrolysed into a form lessa* irritating to the child's immune system.
Blood samples are taken regularly from children randomized into these
groups with parental consent. The appearance of so-called diabetes
markers is observed, up to age of two years with some children and six
years in some. Some children have also been taken stool and saliva
samples to find out which part gut flora plays.
FinDia study tests the hypotesis, that cow milk -based infant formula
insulin can start antibody production in an infant, which can later
lead to destruction of pancreatec cellss secreting insulin, weaking of
insulin production and onset of diabetes.
Two research infant formula are used in the study. In one, at attempt
has been made to remove bovine insulin using methods described in a
patent owned by Valio. One of the inventors of this patented invention
is the director of the FinDia study, who now is employed by NPHI. The
other research formula is a special formula which is also on the
market, and which has traditionally been used to treat allegic
children; in this formula, all cow milk proteins, including insulin,
have been hydrolysed.
The research is carried out under the lead of National Public Health
Institute and one funder is Valio. The research data and samples are
collected in Kuopio University Hospital, Central Finland Central
Hospital and in Kätilöopisto Maternity Hospital in Helsinki.
In Finland, yearly ca. 500 children get ill with diabetes, which is a
disease burdensome to the families and expensive to society: in
addition to the human burden, the cost to society is ca. one million
euros per child. According to the hypothesis which is tested in the
Findia study, up to one third of diabetes cases could be prevented.
Study subject rights and trust must not be allowed to be endangered
In the FinDia study, an effort has been made to try and follow the
good principles of medical research followed in Finnish hospitals.
The study group's aim has been to give all essential information
regarding the study to parents, in an understandable form. A central
basis in the action of National Public Health Institute is that the
study subjects' trust will be preserved. Only in this way can it be
guaranteed, that research and prevention of significant
chronic diseases will not be endangered.
It is important, that the Parliamentary Ombudsman has processed and
taken a stand on the practices of medical research from the point of
view of oversight, good government and basic and human
rights. Ombudsman's statement lends itself to directing and
standardizing the researcher's practices in medical research
concerning authoring protocols, appraisal and approval and carrying
out and overseeing studyes. The legislation concerning medical studies
is still quite young and in many of the issues the ombudsman has
processed, practices have differed in various organizations and
research institutes.
National Public Health Institute will take ombudsman's remarks under
advicement when it develops and make instructions for it's research
practices.
Furthermore, on the issues presented in the Helsingin Sanomat article,
the following be noted:
* Blood samples taken from newborn's cord have not been studied
without a written consent obtained from parents. Parents have been
informed about the study before birth in maternity services or in an
invitation to ultrasound diagnostic. Some of the parents however could
not be reaches before birth. On the other hand, some mothers didn't
have the consent form with them when they arrived to labor. In these
few cases the cord blood sample was acquired from the cord which was
normally unattached, but after that, the sample was sent to be studied
only after signing the consent form. If consent could not be obtained,
the sample was discarded.
* Changes in the research protocol have been notified to the parents:
taking of stool samples or yearly blood samples until the age of 6
cannot happen without parental knowledge.
* The aim of the study has not been to increase the use of infant
formula at the expense of breastfeeding. Formula distributed has not
been a payment for participating in the study. The aim is to study the
part dietary bovine insulin plays in onset of type 1 diabetes in
general. The participants were encouraged to breastfeed and
encouragement succeeded so well, that infants in the study were
exclusively breastfed longer than Finnish children in the average.
* The claim that breast milk, in addition to it's uncontroverted
health benefits, protects from diabetes better than infant formula, is
scientifically controversial and one of the questions the research
tries to answer.
* The study is not a study by Valio and NPHI, but a study by NPHI,
where one of the funders if Valio. The results of the study will be
published in scientific publications and will be freely usable by the
scientific community.
* The PI's share in the patent owned by Valio which relates to the
study setup, should in NPHI's opinion have been clearly disclosed both
in the participant information statement and the protocol. NPHI will
clarify it's practices and instructions in the future also in this
regard.
* FinDia study has one, responsible medically trained researcher in
NPHI. In addition, each hospital which partakes in the study has a
responsible pediatrician and research nurse. This has been done to
guarantee childrens' safety.
For more information
Administrative Director
Jaakko Penttinen
National Public Health Institute
tel. (09) 4744 8203
firstname.lastname@ktl.fi
In the one report of parent's experience in the media, interview in newspaper Savon Sanomat in Kuopio,
the interviewed parents told they they heard about the study first time while in
labor in the hospital. They were asked if they consented to the study. They responded: do as you will (somewhat preoccupied with the issue of childbirth, I guess). Neither of them remembers signing anything, and they say they don't really know what was the aim of the research.
Savon Savomat article (in Finnish, subscription required)
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