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Release on bile acids as a heart treatment wrongly equates success in mice with human outcomes

Maintaining a healthy heart through bile acids

Our Review Summary

Human Heart AnatomyThis release falls short in providing the reader with useful takeaway information about an important and interesting study published in PLOS ONE. The study involved  the use of bile acids to prevent cardiac fibrosis in mice. The use of hyperbole, beginning with the title, the lack of adequate information about the study design, limitations and results, along with a suggestion that the treatment is even close to use in humans, is unfortunate.

The study is important in that it adds to the existing knowledge about fibrosis in the heart and possible ways to prevent its occurrence. The release does little to demonstrate that fact in transparent ways.

 

Why This Matters

A new basic science discovery by researchers at the University of Alberta and McGill might translate into useful treatments for some people with heart failure over a decade from now (or never). The folks in Edmonton are understandably proud of their researchers, but contrary to the language of the release, their discovery offers no quick fix for anyone currently suffering from heart failure.

One bile acid derivative did prevent heart failure in one strain of mutant mice, but it did not reverse or treat heart failure. Fibrosis is just one feature of “heart failure” which is really a diverse set of conditions, and it is possible a future treatment based on this research could make some patients feel better and live longer. While we currently have some medical treatments (ACE inhibitors, beta blockers, aldosterone antagonists, high tech pacemakers and defibrillators) that are shown to do that for certain patient groups, we still have no cure for heart failure. After years of additional research, the discovery in Alberta might or might not lead to additional treatments for congestive heart failure.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Applicable

At this stage of the research, cost is not of major concern. Having said that, tauroursodeoxycholic acid or TUDCA (the bile salt used in the experiments) is readily available from health food stores (for better or worse) and is relatively inexpensive.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Beginning with the headline (“Canadian discovery may soon lead to the prevention of cardiac fibrosis”) and first sentence (“Groundbreaking research from the University of Alberta and McGill University…”) the release over reaches in its description of benefits — at least to humans, transgenic mice however should be thrilled.

Jumping directly from a mouse model to humans is simply wrong in our view.  As we pointed out above, suggesting that a drug in a pre-clinical study  “…offers hope to those who are living with heart failure,”  given the long and arduous process of regulatory approval does a disservice to people living with the disease.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The research paper does not include any statement about potential toxicity other than to point out that none of the 162 mice died prior to the conclusion of the study. The release is silent on the issue. A few words about the potential toxicity (or the absence of risk if that’s the case) of TUDCA which is commercially available and has been studied for the treatment of biliary cirrhosis would have been in order.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release provides no information about the study (other than to say it was preclinical), nothing about study methods or results. It is not until the 8th paragraph of the 11 paragraph release that the reader is given a hint that the study was not conducted in humans: “The team is now pushing forward with additional studies to see if the same therapeutic effect can be achieved in humans.”

Although the title suggests a bile acid was used in the experiments, the release does not specify TUDCA by name.

Does the news release commit disease-mongering?

Satisfactory

There is little evidence of disease mongering. The information on heart disease is on point, although the 30% one-year mortality rate is higher than the often cited Meta-analysis Global Group in Chronic Heart Failure (MAGGIC), a 2012 study of 41,972 patients which found a 12-14% annual mortality rate.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release clearly notes the funding source, the Canadian Institute for Health Research.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release does not mention any of the existing treatments (both pharmacologic and device related) that are available to improve the symptoms of people living with heart failure. To the contrary, the release overly dramatizes the current state of heart failure treatments and the value of this early stage intervention with these statements:

“It [the study] offers hope to those who are living with heart failure,”

“Currently patients with heart failure have poor quality of life and a dismal prognosis. Improving their quality of life will do wonders for these individuals.”

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The release is silent on the availability of TUDCA, the bile salt used in the study. As noted above, it is available commercially as a supplement. However, due to the pre-clinical nature of the research it is premature and ill-advised to rely on TUDCA for cardiac fibrosis prevention.

Does the news release establish the true novelty of the approach?

Not Satisfactory

Groundbreaking discoveries are very rare events. Rather, medical discovery is more commonly a process of iteration, adding to existing information. Bile acids have been tested in humans suffering from heart failure previously, adding to an accumulating knowledge. (See: J Am Coll Cardiol. 59(6):585-92, 2012 Feb 7, a human trial that found improvement in peak post-ischemic blood flow, an obscure test sometimes used in heart attack and stroke research, but no improvement in how well patients functioned).

The Edmonton study importantly adds to the discussion. The release notes:”Groundbreaking research from the University of Alberta and McGill University has opened the door towards the future prevention of cardiac fibrosis.”  We suggest that the door was opened by previous research and this study opened it a bit wider.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

As we have pointed out on other occasions, the use of “groundbreaking” in a release is by and large unjustified but is becoming more commonplace across many platforms. (According to the Google Ngram Viewer, an online search engine that charts frequencies on the use of specific terms, the use of “groundbreaking” in books increased 175% from 1998 to 2007.)

Additional language in the release, including the statements below, belie the fact that the study was conducted in transgenic mice.

“The bottom line is that this shows for the first time that cardiac fibrosis is preventable.”

“It offers hope to those who are living with heart failure,”

The study is important and may lead to new options for treatment or prevention. The use of “groundbreaking” in its description takes away from the scientific significance of the work.

Total Score: 2 of 9 Satisfactory

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