Monday, February 7, 2011

Why Doesn't the Karolinska Institute Want To Disclose How They Conducted Their Research On Snus?

On February 7, Dagens Industri, Sweden’s prestigious business newspaper, published my commentary on snus misinformation emanating from the Karolinska Institute, Sweden’s premier research institution. The commentary is available in Swedish (here); the English version of my submission follows. I will post a detailed description of the Karolinska Institute misinformation in a few days.

Published in Dagens Industri, February 7, 2011

Many research studies from Sweden have not found any health risks from snus use, but researchers at the Karolinska Institute have produced a series of reports, based on a large cohort of Swedish construction workers, that emphasize very small risks for esophagus and pancreas cancer and fatal heart attack and stroke.

The KI reports do not change these indisputable scientific facts: the health risks from the use of Swedish snus are so low that they are difficult to measure with modern epidemiologic methods. Snus use by Swedish men has resulted in the lowest rates of smoking-related diseases and deaths in Europe for the past sixty years.

However, the KI studies have obvious technical problems and contradictions, and I have documented these concerns in medical journals. For example, in 1994 Dr. Gunilla Bolinder studied 135,000 Swedish construction workers who had enrolled in a health program from 1971 to 1974. She found that snus users had elevated risks for cardiovascular diseases.

But in 2007 another KI study excluded the 1971-74 workers because of “ambiguities” in tobacco use. Then another KI-study in 2008 included them.

These problems are unacceptable from a scientific perspective, and I gave the KI researchers several opportunities to resolve them. There was no response.

Over two years ago I asked KI researchers for access to the construction worker data so that their findings could be validated. In the past the KI has given data to American researchers while fully protecting the identity of the participants. But the KI refused my request.

I was at an impasse with the KI from a scientific perspective, so I pursued the matter in the administrative court as a last resort. The court ruled that the data is a matter of public record, and it encouraged KI to make a thorough and comprehensive assessment of which data can be disclosed. But the institute has twice failed to comply with the court’s instructions, and it has provided no reasonable explanation for its intransigence.

KI – which in this respect is a Swedish authority – recently decided that I should be granted partial access to the data. But not digitally – which is customary – but only via pieces of paper. In addition KI will remove information about health conditions, i.e. the very information that I want to validate! This means that I would get hundreds of thousands of pages of worthless paper, for which KI has the right to invoice me.

This cannot be seen as anything but pure obstruction, and KI’s position is that its research is exempt from validation.

Researchers at KI have more than implied that I am running the errands of the tobacco industry. That is of course not the case. For years my university has accepted unrestricted funding from tobacco manufacturers including Swedish Match. This is very common in the U.S., as well as in Europe. We would never – nor would KI – let our funding direct the focus or results of our research.

Personally I have conducted tobacco research for two decades, and I developed a deep understanding of Swedish snus as a visiting scientist at the University of Umeå in 2002.

At first glance this matter appears to be just a minor dispute between a sole American professor and a prestigious and powerful Swedish research institute. I would argue the issue is bigger than that.

The health risks identified in the KI studies are the raison d’être for the ban on snus in the E.U. (except Sweden), but it has also had a profound impact on tobacco regulation in the U.S. and other countries.

It would be a tragedy if snus restrictions and prohibitions were improperly based on exaggerated or fictitious health risks. As a result, millions of inveterate smokers outside Sweden might never know that snus is a much safer substitute for cigarettes.

KI’s position is counter to the scientific and ethical principles of data sharing among medical institutions. These principles require that scientific results are open to challenge by other scientists to determine their accuracy and integrity.

The best solutions for scientific debates are not found in the courts. I therefore hope that KI decides to follow the practices of the world of medical research. If the KI does not release the data, it risks damaging its outstanding international reputation.

Professor Brad Rodu
University of Louisville, U.S.A.

1 comment:

Anonymous said...

In fact, this is typical arogant KI's attitude. Once they grant outstanding scientists with the Nobel prize, they think they rule the world. I have been working at KI as a postdoctoral researcher and saw how KI act against a law and doesn't take any responsibility for that. Shame on you KI!