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Vyvanse – A life cycle drug? Or disease mongering?

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The following is a guest blog post by Dr. Susan Molchan, one of our independent expert editorial contributors.


Vyvanse logoCould an article in the scientific journal Psychopharmacology, “New onset executive function difficulties at menopause: a possible role for lisdexamfetamine,” be the first shot across the graying marketplace for another “disease” for the brand name stimulant Vyvanse? Initially approved for attention-deficit disorder, with a fresh stamp of FDA approval for binge-eating disorder, Shire Pharmaceuticals sponsored a study to see if Vyvanse might help women with impaired “executive function” during menopause and the menopausal transition.

Executive function refers to the abilities to plan, organize, and problem solve. Multi-tasking is an example of high-level executive functioning. Hmmmm . . . we know who’s best at that.

The authors of the journal article note, “Reports of cognitive decline, particularly in the domains of executive functions, are common among menopausal women.” As evidence they cite an article by first author Dr. C. Neill Epperson of the Penn department of psychiatry, who at the time also was receiving financial support from Shire. The cited study didn’t investigate executive function, but reported a slight decline in one memory test during the menopausal transition.

The authors and the press release from Penn (which we reviewed on this site) imply that remedying this situation for postmenopausal women should be “a major public health goal.” Wow. With the average age at menopause being 52, how are so many women struggling to function in their jobs as doctors, lawyers, teachers, journalists, etc.? Maybe these women shouldn’t be left alone with grandchildren (who are hopefully focused and becalmed on Vyvanse themselves) until they’re perked up with Vyvanse.

But this would clearly be over-reacting, because actually no evidence exists that women’s executive function or memory or any other brain function suffers during menopause.

The idea that women have memory and other cognitive problems around the time of menopause and during menopause is “a long-standing, but unproven hypothesis,” according to the authors of the longest and largest study on the topic. The six-year Study of Women’s Health Across the Nation (SWAN) looked at 1,903 women in the U.S. It found that during perimenopause, learning a test of mental processing speed became slightly impaired, with no changes on other tests of attention or memory, with the exception of a slight decrease in the same test in women who were depressed. The researchers found no changes in cognitive performance during menopause itself.

In the 32 women that Dr. Epperson and colleagues studied, Vyvanse “improved” scores on a subjective questionnaire used in attention deficit disorder studies, as well as reportedly on some objective tests of memory and attention. Actually for the latter, by my read, the marginally statistical significance is lost because correction for multiple comparisons was not done.

Most groups tested will come out as having an effect on the questionnaire if they report using any stimulant, including coffee. Imagine answering questions before and after your coffee in the morning relating to how well you’re getting tasks going, ability to concentrate, daytime drowsiness, and forgetfulness.

Studies have noted that a significant number of women experience symptoms of depression and anxiety as they transition into menopause, and these may relate to complaints, including of memory and other cognitive problems. Women going through menopause also often have problems with sleep. The last thing someone with anxiety and trouble sleeping needs is a stimulant. Nor do older women need a drug that can increase risk of heart arrhythmias, heart attack, and stroke. Nor one that risks abuse and dependence—this one not only has shades of diet drugs from the ‘50s and ‘60s; Vyvanse releases the same dextroamphetamine that was in one of the most popular, Dexedrine®.

So if Shire doesn’t get women to take their drug because they think it will help them with out of control eating and weight loss (though it’s not officially marketed for the latter), they’ll catch them on the downhill for being dotty.

Years ago, drug companies funded researchers and pushed doctors to prescribe hormone replacement therapy as another fix for postmenopausal women. Is this the latest iteration of a similar scheme? With the help of docs at fine institutions like Penn, we’ll watch with interest as this latest example of disease mongering unfolds.

None of the news coverage we saw included any discussion of the limitations of such a small, 32-person study.

Everyday Health reported: “How ADHD Drugs May Ease Menopause Symptoms.”

HealthDay News reported, “ADHD Drug Vyvanse Improves Cognitive Decline in Menopausal Women.”

Medscape included this:

Pauline M. Maki, PhD, professor of psychiatry and psychology at the University of Illinois, in Chicago, and president of the North American Menopause Society, noted that although the drug was effective in improving memory in this population, “it would be wrong to conclude from this study that women get ADHD when they transition through the menopause.”

“The entry criteria for this trial were not focused solely on memory complaints per se. Instead, they focused on aspects of executive functions that are disturbed in ADHD, such as organizing work activities and paying attention. The level of cognitive complaints at study entry was elevated and disturbing to the women, but only a very small minority of them, just 5.5%, had cognitive complaints that were as severe as those seen in ADHD,” said Dr Maki.

The study “informs our understanding of the neurobiological basis of memory complaints in midlife women and suggests there is a strong prefrontal component to those changes,” Dr Maki said.

“It is interesting that the stimulant improved subjective aspects of executive function but not objective performance on executive function tests. Psychostimulants improve prefrontal function in other populations, such as ADHD. It might be that more complex tests of executive function would have shown improvements with treatment. The finding that story recall improved with treatment contributes to the growing body of evidence that memory complaints in midlife women reflect changes in prefrontal function,” she said.

The study was supported by Shire, the National Institute of Mental Health, the National Institute on Aging, and the National Institute on Drug Abuse. Dr Epperson reports financial relationships with Shire, Novartis, Pfizer, Johnson & Johnson, Abbott, Abbvie, and Merck. Dr Maki reports financial relationships with Abbott, Noven, and Pfizer.

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Comments (4)

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felonious grammar

June 25, 2015 at 6:49 pm

I have MS, hot flashes made the pain unbearable and made adequate and regular sleep impossible; so, I love my hormone replacements. Otherwise, I doubt that I would have asked for them.

Psychiatry has made a killing preying on women’s health issues and insecurities. Menopause changes us substantially, psychologically and physically, but most women manage to deal with it the way they’ve dealt with all other women’s health issues. It’s good to see this effort to pathologize menopause and turn middle-aged women into tweekers out of fear countered well.

Thank you.

Thank you.

john tucker

June 27, 2015 at 12:16 am

A couple of points.
1) None of the authors of this paper are Shire employees and the study was funded in part by NIMH.
2) The suggestion that Shire is trying to create a new disease that it can get this drug approved for fails to take into account the fact that the patent on the drug expires in just 8 years. Given that the FDA requires adequately powered cardiovascular safety studies for drugs that raise pulse and blood pressure, there is virtually no chance that the drug could be approved for such an indication in that time frame, and thus no motivation for the company to engage in the behavior it is accused of here. This is not “disease mongering” by industry, but careerism on the part of a couple of academics.
3. p values that start with two zeros are not “marginally statistically significant.”
4. The assertion that “Most groups tested will come out as having an effect on the questionnaire if they report using any stimulant, including coffee” is unsupported. There is considerable debate in the literature as to whether the very small positive effects seen from caffeine in cognition assays is simply due to relief from caffeine withdrawal symptoms. In contrast, the pro-concentration effects of amphetamine are among the most well-characterized in psychopharmacology.
The comments section begins with a warning that “We will delete comments that include unfounded allegations and unverified facts.” Shouldn’t this apply equally to the articles.?

    Susan Molchan, MD

    June 28, 2015 at 8:47 pm

    Thanks for your comments Mr. Tucker. To address your points, though none of the authors were Shire employees, the study nonetheless was funded by Shire and the PI has received funding from Shire for some time. Its well know that corporate-funded studies come out in overwhelmingly in favor of the corporate funded study and drug. And why would one expect otherwise? Why would a company lay their money down on a drug that was a bad bet?
    Whether the drug eventually is approved or not for something along the line of post-menopausal cognitive impairment may be immaterial, as the FDA is currently being sued for disallowing off-label marketing, and unfortunate as it is, we may see more of it.
    The p-values referred to that are significant out to 2 zeros are those associated with the subjective scale that was administered. This doesn’t change the fact the objective measures, if appropriately corrected for stat significance, would not come out as stat significant. Nor would it change the fact that there is little data to support the claim that there is any cognitive impairment in women during menopause.
    And yes, amphetamine’s a great stimulant, but so is caffeine http://pharmrev.aspetjournals.org/content/51/1/83.long. Regardless, people would probably be best off just going going for a walk & skip the whole drug thing: http://psychsocgerontology.oxfordjournals.org/content/early/2014/12/19/geronb.gbu167.long (one of many studies showing that aerobic exercise/cardiovascular fitness helps executive function, memory and attenuates age-related cognitive decline.)

      Steve

      July 13, 2015 at 5:17 pm

      Gosh, Susan, there is just no way to make multi-billions marketing exercise, is there? Thanks for the top about off-label marketing – always a good way to get around the FDA, do a study, get positive results, and claim “there is literature support for…” I still can’t believe the FDA went for a stimulant to treat “binge eating disorder.” I suppose wiring your jaw shut is also a “treatment” in the crudest sense, but any moron knows that stimulants decrease appetite. It’s about as sensible as prescribing marijuana for anorexia, though the side effects and dangers are decidedly worse!