Diet drug shows pharma's influence in medical studies

Saxenda is an injectable weight-loss drug that is approved for patients with a body mass index above 30.
Saxenda is an injectable weight-loss drug that is approved for patients with a body mass index above 30.
Posted: January 05, 2016

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."

Greenway, the review author, said Novo Nordisk proposed the idea for the article, to reinforce the idea that obesity is a medical condition.

"They said, 'Can you help write a review to support what is in the literature, to show there are reasons why this should be thought of as a chronic disease rather than bad habits?' " he said.

The writing assistance was provided by a consulting firm called AXON Communications, which has offices in London, Toronto, and New York, but Greenway said he held final responsibility for the content.

"It was sort of a cooperative effort," Greenway said. "I came up with things, and they came up with things."

He acknowledged the lack of long-term evidence for the drug, and said that generally, any weight lost would likely be regained when the patient stops taking it. Still, he stood by his statement that medicine or surgery offer the best chance for success.

In the past, drugmakers actually wrote manuscripts and later found researchers to put their names on them - a practice known as ghostwriting.

Not the case here, Greenway said.

"There certainly were abuses in the past, and that's why I think there's more and more interest in having people be up-front," he said. "Transparency is a good thing. I think that people can make their own judgments."

In a statement, Novo Nordisk said it follows good publication practice guidelines and disclosure requirements spelled out in the Annals of Internal Medicine, which were revised last year to state that authors should be involved throughout writing and publication, and clarify the role of authors. Among the rules:

"The authors should take responsibility for the way in which research findings are presented and published, be fully involved at all stages of publication and presentation development, and be willing to take public responsibility for all aspects of the work."

Participating in journal articles is just one way Novo Nordisk is promoting Saxenda.

In a December 2014 news release after Saxenda was approved by the U.S. Food and Drug Administration, the company included a favorable quote from Joseph Nadglowski, president and chief executive officer of Obesity Action Coalition, a patient advocacy group. He also testified in favor of the drug before an FDA advisory panel earlier that year.

Novo Nordisk is a platinum member of Obesity Action Coalition's Chairman's Council, meaning it donated at least $100,000, according to the nonprofit's website.

The drugmaker also was a platinum sponsor of the nonprofit's Your Weight Matters convention in 2015, at a cost of $50,000, and a gold sponsor in 2014, for $25,000, according to the site.

Nadglowski said the donations do not affect what he says, and that he routinely provides quotes for other manufacturers of obesity drugs and devices, some of whom also give money to Obesity Action Coalition.

Nadglowski said his group welcomes all new additions to the fight against obesity.

"What we see it as is a continuum of care, so there's going to be a need for multiple tools in the toolbox," Nadglowski said. "None of these products, devices, and drugs are perfect solutions."

tavril@phillynews.com

215-854-2430@TomAvril1

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