Diet Drug Shows Pharma’s Influence in Medical Studies

With the new year come thoughts of losing weight, and for some that may mean trying a new weight-loss drug.

Weight-loss medications have had a checkered history. But after a long drought in the diet drug market, several new ones have recently been introduced. Last April, drugmaker Novo Nordisk announced its entry, a daily injection called Saxenda, which contains a higher dose of the active ingredient in the company’s diabetes drug Victoza.

It’s too soon to say what the $1,000-per-month Saxenda will mean for long-term weight control.

But it provides a window into how the pharmaceutical industry is influencing the portrayal of its products in academic journals, a development that has some experts worried.

The same week Saxenda was announced, a top obesity research journal posted a preview of an article that made a strong case for weight-loss pharmaceuticals, specifically touting liraglutide, the scientific name for Saxenda.

At the end of the nine-page article, author Frank L. Greenway, a physician and researcher, disclosed that the drugmaker had paid a consultant to provide him with “writing assistance” on the manuscript. What’s more, he wrote that the company, which has U.S. operations in Plainsboro, N.J., got to review the article before publication. In an interview, Greenway said he wrote the article at Novo Nordisk’s suggestion.

Company involvement in the writing of journal articles has gone on for years, and is increasingly out in the open amid calls for greater transparency. But ethics experts caution that while disclosure is a positive step, it is not a cure-all for bias.

The content must still be judged on its merits, said Harvard’s Aaron S. Kesselheim, a physician and health policy researcher at Brigham and Women’s Hospital in Boston. And that is not a given, with disclosure notices often appearing in small type at the end of manuscripts, escaping the notice of busy physicians, he said.

“It would be a danger for us to assume that simply because something is disclosed that we don’t have anything else to worry about in terms of the ethics of the issue,” Kesselheim said.

The Greenway article, in the International Journal of Obesity, was one of several academic articles last year whose authors disclosed that Novo Nordisk funded writing assistance and reviewed them before publication.

The piece by Greenway, a professor at Louisiana State University’s Pennington Biomedical Research Center, was a broad review of the physiology of weight loss.

Novo Nordisk’s Saxenda is not mentioned until near the end – by its scientific name, liraglutide. The piece does not note its specific side effects, which include nausea, diarrhea, and pancreatitis.

In general, the piece espouses the use of medicine and surgery as the best weapons against obesity, rather than diet and exercise alone.

“It is difficult to overcome physiology with behaviour,” Greenway wrote. “Weight-loss medications and surgery change the physiology of body-weight regulation and are the best chance for long-term success.”

Diana Zuckerman, president of the National Center for Health Research, a think tank and consumer-advocacy group in Washington, took issue with that statement.

It is true that most people have trouble losing weight and keeping off the pounds by restricting their diet, and that bariatric surgery has helped many obese patients lose weight over the long term. But there is scant long-term evidence for medication, she said.

Saxenda, approved primarily for people with a body mass index over 30, can reduce appetite by mimicking the effect of a hormone produced in the gut, resulting in a loss of 5 to 10 percent of body weight. That amount is modest because appetite is only part of the battle, said Zuckerman, who holds a doctorate in psychology and is a former fellow at the University of Pennsylvania Center for Bioethics.

“People don’t become obese because they’re hungry. Realistically, we all eat for a lot of other reasons,” Zuckerman said, calling the company’s involvement with the article “pretty outrageous.” […]

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