by Marion Nestle

Currently browsing posts about: Diet-drugs

Dec 11 2023

Conflicted interests: obesity drugs, alcohol, clinical trials

DRUGS

Here’s the headline: Maker of Wegovy, Ozempic showers money on U.S. obesity doctors

Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.

What’s extraordinary about this situation is the amounts.  Some doctors got millions.

This account follows one about similar efforts in the UK: Revealed: experts who praised new ‘skinny jab’ received payments from drug maker.

The drug giant behind weight loss injections newly approved for NHS use spent millions in just three years on an “orchestrated PR campaign” to boost its UK influence.  As part of its strategy, Novo Nordisk paid £21.7m to health organisations and professionals who in some cases went on to praise the treatment without always making clear their links to the firm, an Observer investigation has found.

Novo Nordisk knew what it was doing, and its efforts (presumably legal) are certainly paying off.

ALCOHOL

The headline: Scientists in Discredited Alcohol Study Will Not Advise U.S. on Drinking Guidelines: Two researchers with ties to beer and liquor companies had been named to a panel that will review the health evidence on alcohol consumption. But after a New York Times story was published, the panel’s organizers decided to drop them.

Five years ago, the National Institutes of Health abruptly pulled the plug on an ambitious study about the health effects of moderate drinking. The reason: The trial’s principal scientist and officials from the federal agency’s own alcohol division had solicited $60 million for the research from alcohol manufacturers, a conflict of interest and a violation of federal policy.

I wrote about that in a previous post.

I’m told by people in the know that I should not be too hard on the scientists.  NIH told them it would not fund the study and they should get the funding from industry.  If true, that is unfortunate.

For sure, NIH is not interested in nutrition research except for genetically based “Precision” nutrition aimed at individuals.  That leaves population studies out of the picture.  Unfortunate, indeed.

CLINICAL TRIALS

The study: Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

Among 600 clinical trials with a median sample size of 415  participants:

  • 409 (68.2%) had industry funding
  • 303 (50.5%) were exclusively industry-funded
  • 354 (59.0%) had industry authors
  • 280 (46.6%) involved industry analysts
  • 125 (20.8%) were analyzed exclusively by industry analysts.

Among industry-funded trials:

  • 364 (89.0%) reached conclusions favoring the sponsor.

Industry involvement in research in general and in nutrition research in particular deserves close scrutiny and much skepticism.

Drug companies are required to do research and to find their own funding.  That is not true of nutrition.

Everyone should be lobbying for more independent funding for nutrition research.

Jul 12 2021

Conflicted interests? Drugs vs supplements for obesity

Lots of people take supplements in the hope that they will help with body weight.  This is a big market.  Drug companies want in on it.  Most drugs don’t work, or have deal-breaking side effects.  In June,  The FDA approved Novo Nordisk’s Semaglutide for obesity management.

I subscribe to the Obesity and Energetics newsletter, which sends out weekly lists of research, articles, and commentary on those topics—a great way to stay up on current literature.

On July 2, it featured:

This referred to: Perspective: Dietary supplements and alternative therapies for obesity: A Perspective from The Obesity Society’s Clinical Committee.  Srividya Kidambi, John A. Batsis, William T. Donahoo, Ania M. Jastreboff, Scott Kahan, Katherine H. Saunders, Steven B. Heymsfield.  Obesity 23 June 2021.

Our recommendation to clinicians is to consider the lack of evidence for non-FDA-approved dietary supplements and therapies and guide their patients toward tested weight management approaches…we call on regulatory authorities to critically examine the dietary supplement industry, including their role in promoting misleading claims and marketing products that have the potential to harm patients.

I am with the Obesity Society on this one, but what caught my interest was that several of the authors report financial tied to drug companies with interests in pharmacologic approaches to obesity treatment.

Conflicts of interest: SK serves as Medical Editor for TOPS Magazine (TOPS Inc. nonprofit weight loss club) and as Director for the TOPS Center for Metabolic Research at the Medical College of Wisconsin supported by TOPS Inc. JAB’s research reported in this publication was supported in part by the National Institute on Aging of the National Institutes of Health (NIH) under Award Number K23AG051681. JAB reports equity in SynchroHealth LLC. AMJ’s research is supported by the NIH/NIDDK, the American Diabetes Association, Novo Nordisk, and Eli Lilly; she serves as a consultant for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. SKa has served as a consultant for Novo Nordisk, Vivus, Gelesis, and Pfizer. KHS reports an ownership interest in Intellihealth. SBH reports his position on the Medical Advisory Board of Medifast Corp.

The newsletter also featured the article referred to in the Perspective.

When I clicked on this link, it took me to the page where I could download the pdf.  I got the paper at this site.   But before I could read it, I had to see an ad for Novo Nordisk’s drug, Semaglutide.  Then I scrolled down to get the study:  A Systematic Review of Dietary Supplements and Alternative Therapies for Weight Loss.  John A. Batsis, John W. Apolzan, Pamela J. Bagley, Heather B. Blunt, Vidita Divan, Sonia Gill, Angela Golden, Shalini Gundumraj, Steven B. Heymsfield, Scott Kahan, Katherine Kopatsis … Obesity (2021) 29, 1102-1113

Study conclusion: “There is weak evidence for the efficacy of dietary supplements and alternative therapies.”

Authors’ disclosure: JAB reports equity in SynchroHealth LLC. AG reports consulting with Novo Nordisk and Unjury. SH reports personal fees from Medifast. SKa reports personal fees from Novo Nordisk, Pfizer, Vivus, and Gelesis. DR reports consulting and speaking fees for Novo Nordisk and Astra Zeneca. KHS has a relationship with Intellihealth Inc. SK is the medical director for TOPS Center for Metabolic Health at the Medical College of Wisconsin, which is supported by TOPS Inc. SBH reports his position on the Medical Advisory Board of Medifast Corp.

I much prefer dietary approaches to weight management and policy strategies to make healthy diets the easy choice.

I am almost never in favor of supplements.  The evidence that they do much beyond placebo effects is usually pretty weak.

The ad gives the side effects for Semiglutide; it has to.

My point: all of this seems to be about marketing Semiglutide.

May 11 2012

FDA panel recommends approval of another iffy weight-loss drug

I was riveted by an article in today’s New York Times about the latest decision of an FDA drug advisory panel.

The panel voted to approve a new weight-loss drug, lorcaserin.  The vote was mixed: 18 for approval, 4 against, and 1 abstention. The majority felt that the benefits outweighed the risks and that even if there were risks, “new tools are needed to treat a major health problem.”

The benefits are worth a look.

  • People taking the drug lost an average of  5.8% of their body weight in a year, compared to 2.5% for people taking a placebo.  This difference is below the FDA’s standard for approval which requires a 5% difference.
  • Among those taking the drug, 47% lost at least 5 percent of their weight after a year, whereas only 23% of those taking the placebo did so.  This meets a second FDA standard for approval.

What about the risks?  The drug:

  • Causes tumors in rats (although perhaps at higher doses than might be taken by people).
  • Damages heart valves (in the same way the withdrawn drug, Fen-Phen, did).

Also in the Times is a piece by Dr. Danielle Ofri on her experience with patients who want weight-loss drugs.

She quotes from an essay called “Lemons for Obesity” by Dr. Michael S. Lauer, who was a minority voter on the FDA panel that approved the weight-loss drug Qnexa earlier this year.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Shares of the maker of the drug nearly doubled after the decision.  The Times reported that “Arguments by investors have been passionate.”

People who cannot easily lose weight are desperate for help.

But is it ethical to put them at this kind of risk?

Aug 23 2011

New study: healthy diets produce health benefits

The latest issue of JAMA has a paper on a “portfolio” of dietary means to reduce blood cholesterol levels.

The paper is likely to get lots of press because it concludes that consuming the “portfolio”—a combination of plant sterols, soy protein, viscous fibers, and nuts—does a better job of lowering LDL-cholesterol (the “bad” kind) than does dietary advice to reduce saturated fat.

The paper is unusually difficult to read  (see the Abstract, for example).  But besides that, I interpret the study in part as a drug trial.

One look at the Abstract and I immediately suspected that this study must have been sponsored by a maker of plant sterol margarines.

Bingo!

Plant sterols are well established to reduce blood cholesterol levels.  Unilever, which makes Take Control margarines, is one of the sponsors.

As I interpret it, the study shows:

  • Advising people who weigh an average of 76 kg (167 pounds) to consume a healthy diet doesn’t work.  Study subjects did not change their diets by much during the six months of the trial.  No news here.
  • Advising people to add things to their diets has a better chance of succeeding than advising taking things away (like saturated fat).
  • All of the portfolio items have been established to lower blood cholesterol in clinical trials, although the evidence for soy protein seems a bit iffy these days.
  • The study does not distinguish between the relative effects of soy protein, fiber, or cholesterol lowering margarines. If soy is eliminated, that leaves fiber and margarines. I’m guessing the margarines were the critical factor. Hence: a partial drug trial.

And because my book on calories is coming out next March, I must point out that the study groups reported losing  losing small amounts of weight, which means they must also have reduced their calorie intake.  Weight loss alone should help with blood cholesterol.

The take-home message: if you really do substitute nuts, sources of fiber, and healthy foods for whatever less healthful foods you used to eat, you ought to get some health benefit, with or without plant sterol margarines.

QED: Healthy diets produce health benefits.

It’s always nice to see that confirmed.

 

 

Feb 4 2009

FDA cracks down on weight loss products

The FDA has its hands full these days, what with peanut butter, no commissioner, and Daschle withdrawing for consideration as secretary of Health and Human Services (the FDA’s parent agency).  Even so, the FDA is concerned about weight loss supplements that it considers fraudulent, and has now gone after 70 of them.  The FDA has a lot on its plate, as it were, and let’s hope the new administration figures out a way to make oversight of the food supply a priority.

February 10 update: the New York Times has a long piece on this problem.  Turns out that a lot of these so-called herbal products actually contain weight loss drugs of one kind or another.  They are not supposed to.

Oct 24 2007

The selling of Alli

Glaxo, the company that makes Alli (a.k.a. Xenical), says it has sold 2 million packages of the diet drug since June when the FDA approved over-the-counter sales. How did Glaxo do this? In interesting ways, says the Wall Street Journal.

The New York Times says the company says 70% of people taking the drug say they are losing weight. Maybe so, but under some coercion. Eat too much fat while taking the drug and you can expect some messy side effects.  There has to be a better way….