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Claims that niacin prevents miscarriages in humans grossly exaggerated

Historic Discovery Promises to Prevent Miscarriages and Birth Defects Globally

Our Review Summary

This release describes a “double discovery” made by researchers at the Victor Chang Cardiac Research Institute in Australia that, theoretically, will greatly reduce the number of birth defects and miscarriages worldwide. The premise rests on the discovery that genetic mutations causing a deficiency in one type of molecule (Nicotinamide adenine dinucleotide, or NAD) can lead to birth defects in humans. The researchers then tested the impact of vitamin B3 (or niacin) supplements on mouse models engineered to have the same mutations who were deficient in NAD. They found that the mice who had higher levels of niacin were less likely to have offspring with birth defects.

The news release hid the fact that the vitamin supplements (referring only to “preclinical models”) were tested in mice, and not humans. But most worrying was the use of extremely sensationalist language prevalent throughout the release. The language was so overblown that it could give false hope to women without properly describing the limits of the research.

Editor’s note: after our review was underway, the Institute put a clarifying statement on its website that addresses some — but not all — of our concerns with the news release. Clarifications are welcome and helpful, but they miss those who only saw the original, incomplete description of the research. We discuss this more under our last criterion, Unjustifiable Language.

 

Why This Matters

As the release itself mentioned, birth defects and miscarriages affect millions of families each year, and can be tragic for all involved. Giving women false hope that a vitamin supplement yet untested in humans may end all miscarriages and birth defects is irresponsible.

The release generated worldwide news coverage, some of it initially as misleading as the news release. Some news organizations later revised their stories to include cautions from experts not involved with the research.

Sydney Morning Herald: Breakthrough discovery finds cause and potential preventative for miscarriage, multiple births defects, Victor Chang Institute scientists announce

BBC: Vitamin B3 may prevent miscarriages and birth defects, study suggests

Irish Times: Vitamin B3 could prevent miscarriages and defects, study suggests

CNN: Vitamin B3 may prevent some miscarriages, birth defects, study says

Criteria

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

Not Satisfactory

The cost of the supplement (vitamin B3, also known as niacin) is not mentioned. A quick Google search shows that you can buy it online for less than $10.

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

Not Satisfactory

The news release made no mention of any numbers or figures from the study that put the benefits in context. The release was also misleading since it implied that vitamin B3 supplements could prevent miscarriages and birth defects in humans when this has never been directly studied.

The release seems to combine two sets of research findings: The first is from a 12-year study of 13 human families that found the genetic causes of a rare birth defect called VACTERL association (the cause was found to be a deficiency of the molecule NAD).

The second study was done in mice, who were genetically mutated to have an NAD deficiency, and then were given niacin. The researchers reported that these mice had offspring with fewer birth defects.

Crucially, however, the theory that niacin can prevent birth defects or miscarriages has never been tested in humans. The release was worded in a way that is very misleading considering the amount of human research that still needs to be done.

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

Not Satisfactory

The release made no mention of harms of niacin supplements. Niacin supplements are used clinically and have side effects when used in high doses. According to WebMD, these include a hot “flush” reaction that can be frightening. As dosage increases, other side effects may occur, including liver problems, ulcers, loss of vision, and irregular heartbeat.

There have been enough people worried about niacin side effects that the British Columbia Drug and Poison Information Centre has an FAQ page about the supplement.

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

Not Satisfactory

Although the news release suggests that many types of birth defects could be prevented by niacin supplements, the research study focuses on a specific constellation of birth defects known by the acronym VACTERL, which includes defects in the vertebra, anus, heart, trachea and esophagus, kidney, or limbs. The genetic basis for this combination of defects has not previously been understood.  The researchers identified patients with congenital vertebral and heart defects and performed gene sequencing in their family members to identify mutations that could potentially cause those defects.  They then created genetically engineered mice with the same mutations to see if their offspring had similar defects and if the defects could be prevented by supplementing the diet with niacin.

As previously stated the news release didn’t distinguish between two different studies, allowing the reader to think that niacin supplements had been shown to be effective in humans. The release did mention that one of the trials was conducted on a “preclinical model,” but not until halfway through the release.  Finally, the release did not make it clear enough that niacin may only help prevent miscarriages and birth defects caused by an NAD deficiency. There are many other causes of birth defects and miscarriages, but the release made it sound like this supplement would prevent miscarriages and birth defects from all different causes.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering. The study rightly points out that miscarriages and birth defects affect millions of families worldwide. 

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

Not Satisfactory

The release doesn’t name any of the study’s many public or private foundation funders.

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

Not Satisfactory

The release doesn’t mention any other strategies for preventing miscarriage beyond vitamin B3 supplements.

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

Satisfactory

The news release noted that niacin is available as a dietary supplement.

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

Satisfactory

The release made it clear that the discovery of NAD deficiencies, and how niacin may treat it, are both new.

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

Not Satisfactory

This news release has some of the most sensationalist language that we’ve ever seen, to a level that is truly egregious. The release lauds the discovery as “historic,” “one of the greatest discoveries in pregnancy research,” a “breakthrough,” a “landmark,” “a blockbuster,” “revolutionary.”

“This will change the way pregnant women are cared for around the world,” said the executive director of the Victor Chang Cardiac Research Institute in the release. He also said that this research “will be one of our country’s greatest medical discoveries.”   

Apparently the news release hype generated some backlash since the Institute released an update urging women to continue following their doctor’s orders and not increase their intake of niacin on their own. Yet even as they walked back some of their larger claims (“The Victor Chang Institute would never suggest that this discovery will explain all causes of miscarriage and birth defects”), the update still emphasized that this study was a “significant advance” in the understanding of miscarriages and birth defects.  

Total Score: 3 of 10 Satisfactory

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