Weekly Comment

The bad research debate

The dust is settling on the WHI trial. First came the news that
low-fat diets didn't reduce the risk of breast or colorectal cancer
or cardiovascular disease, then came news that vitamin D and
calcium supplements don't protect against fractures.

In reality, the facts were lost somewhat in the headlines.

Perhaps we didn't see anything from the diet because very few of the women actually met the targets.

We did see a decrease in the number of fractures for the women actually taking the calcium and vitamin D supplements.

Did the headlines reflect this?

The comment, "The cost of bad research", was aimed at highlighting the limitations of the WHI, and it evoked a great response - many thanks to all those who contributed.

Below is a selection of feedback from readers.

To comment further, please contact Stephen Daniells .

People do what people do I listen to consumers three out of four weeks a month, on a variety of topics.

I think the study showed that people do what people do.

And when they do, we don't get the results claimed.

Good writing.

Jacqueline H. Beckley The Understanding & Insight Group, LLC "catalyst for adaptive growth" www.theuandigroup.com

A word for the defence I read with interest your comments on the "low-fat diet" announcements and, while I find them interesting, I have to respectfully disagree with many of your conclusions.

I have not had the opportunity to read the original research article, but I have followed closely the write-ups in the consumer press.

I believe that you are correct in that the message: "low fat diets don't work" is not correct and has been mistakenly trumpeted by the media.

I am not sure the study was as flawed as you contend.

My understanding is that the authors did understand about the differences in types of fats, but the epidemiological data that they were trying to prospectively confirm supported "total fat" not specific types of fat, so that is what they focused on.

I suspect that if the study had been run differently it would have ended up with the same results.

The reason I believe this is that the primary conclusion I drew from the study results is that it is incredibly difficult to get people to change their diets.

The women in the intervention group were extensively (by normal medical intervention standards) counseled on reducing overall fat in their diets.

They attended a series of lectures (I believe 16 in all) at the beginning of the study, followed by quarterly visits with nutritionists.

Even with all of this intervention they did not even come close to hitting the goal of fat reduction that the authors set out to achieve.

For the food industry, this means that providing people the tools to achieve dietary changes is critical.

Whether that means teaching people how to cook, providing convenient access to fresh fruits and vegetables, or reducing the fat and sodium content of processed foods, it is clear that the industry has an opportunity to assist the consumer in making the necessary changes.

It is clear also that without the support from the industry that even the most educated consumers have a tough time meeting the dietary guidelines.

Anyway, I still enjoyed your commentary, and I look forward to more in the future.

Carolyn M. Merkel Ed -

The comment was aimed at providing an alternative view, highlighting the limitations, to those being bandied around by the popular press.

I think, fundamentally, there are several big problems with the WHI dietary intervention study.

The major problem is the fact that the intervention group did not really change their diets sufficiently is probably more a reflection on the participants than the researchers, and could be a major factor in why we "didn't see anything".

If such intervention studies have poor adherence rates, as has been suggested, then this begs the question as to why funding is still available for studies that do not stand a chance of intervening.

If people want to change their diet, they will .

Your comments about implications and opportunities for the food industry is very well made - a point that I did not touch on and that could be interesting to develop.

Clear and responsible journalism Congratulations for your article.

Excellent points.

I couldn't agree more, as a nutritionist and nutrition educator working on diet-related health matters for nearly 25 years.

In your commentary you put my thoughts that I had when reading the news articles on this "research" in most appropriate words.

I find it most disquieting to see that it was possible to collect that amount of money for such a poor study design.

A study design which inevitably shows "no-results"(was this perhaps the intention ?? ...)

and should therefore have even been rejected for the research plans of a graduate student.

Congratulations for your article.

I wish we would see more of that kind of clear and responsible journalism.

PG (PhD in nutrition)

Hitting the nail on the head Congratulations on a well-written and succinct article.

Bad science damages everyone and it would be good to see your article given wider media coverage.

John Davidson Carsebreck Consultants, UK Traceability-Quality-Change From the industry I simply wanted to thank you for taking the time to describe in simple and understandable terms the flaws with the WHI trial.

I am a RD who is often bombarded with questions, concerns and doubts about nutrition when typical articles come out that only describe the conclusion of a study, but never the flaws.

Our society is so confused about science and nutrition, instead of confusing them more; we need to help them put the facts together.

Thanks for your great article!

Kim Shovelin, MPH, RD, LDN Striking a chord Stephen Daniells, your article is the best I have read!

Perhaps the only positive thing is that it teaches us to devise and hopefully directs us to more controlled studies which consider total body health and what it means to the development or prevention of disease.

JoAnn Hattner MPH, RD A word for the defence - part 2 I agree that the low-fat WHI study was costly.

However, in defense of the research design, targeted weight loss, exercise or calorie reduction may have lowered CHD risk and thus confounded any possible effects of a low-fat diet.

Laurita M. Burley, PhD, RD, LD Not quite enough Your informative article made for good reading!

Perhaps one more paragraph could have tied it all together of what we needed to come away with based on the information.

Appreciate the way you described how the flaws of the study sidelined the results -- and more so, any constructive conclusions.

My opinion...women are intuitive about their bodies -- what is needed, but so human in not being able to carry thru their insights.

Also, cultural practices (over cooking vegies, high consumption of refined carbs, etc) and consumer marketing hype all make for difficult navigating of consumer choices and, ultimately, maintaining personal and family health.

What I'd like to see are studies looking for practical nutritional lifestyle: who and why some women are able to achieve and maintain their own and their family's health.

I suspect there are some basic issues: more whole foods, decreased refined sugars and meats, vit supplements, and what I've found --- supplements of probiotics (live bacteria) for GI health.

Jo Valberg Nursing;

Behavioral Health Care

The final word The limitations of the studies have led to people asking how such a project could have received funding.

The entire WHI project cost $725m. It is sobering to think that could have paid for 35500 heart bypass surgeries in the US. Or consider that the UN's FAO, an organization with the mandate "to raise levels of nutrition and standards of living, to improve agricultural productivity, and to better the conditions of rural populations of its member countries," is having increasing difficulty in convincing the people who control the purse strings that its annual budget is worth increasing to offset inflation.

The FAO's budget for 2004-05 was $749m.

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