Migraines, Menopause, and Marketing

By Adriane Fugh-Berman, M.D.

Several states are considering banning sales of prescription information and patient medical records to commercial entities that sell this information to pharmaceutical companies for marketing purposes (see “Over-the-Counter Sales of Medical Records”, in the May/June 2007 WHA). Opponents of such legislation have argued that prescription information informs public health research and policymaking. This is a compelling argument: such records could be used towards the public good. But the research isn’t used in this way, as the following tale illustrates.

An industry study was commissioned by an unnamed pharmaceutical company to find out why a migraine drug had not sold as briskly as had been projected. The marketing study was performed by IMS Management Consulting, a division of IMS Health, the largest of the infor-mation distribution (or data-mining) companies. The study used “anonymized patient-level intelligence,” meaning prescriptions and medical records gathered on individual patients, and identified by number instead of name in order to adhere to patient privacy laws.

IMS attempted to determine why 2003 sales of the company’s migraine drug were far lower than had been forecasted. Hypothesizing that there might be a link between menopausal hormone use and migraine drug use, IMS researchers performed a preliminary analysis that showed a positive correlation between the volume of prescriptions written for menopausal hormone therapy and the volume of prescriptions written for migraines. In other words, sales of the two drugs seemed to be related.

Of course, millions of women abruptly stopped taking menopausal hormones in mid-2002, when the Women’s Health Initiative (WHI) showed that risks outweighed benefits for the most popular estrogen-progestin regimen. Could decreased hormone use have resulted in fewer migraines, thus explaining the anemic sales of the migraine drug? To confirm the connection, the brand team examined the records of 41,403 women who suffered from migraines. They found that, among migraine sufferers who had stopped hormone therapy, prescriptions for migraine drugs dropped by half. During a six-month period, women taking hormone therapy filled an average of 2.94 prescriptions per woman for migraine medication, compared with an average of 1.49 prescriptions during a six-month period after they stopped taking the hormones. More than half of the women (54%) didn’t fill any migraine prescriptions in the six months after quitting hormones.

Well, that’s certainly a large study with some important public health implications. Wondering why you haven’t heard about it? That’s because it wasn’t reported in the medical or public health literature, nor was it reported to national media. The study was outlined in Product Management Today, an industry publication, as an example of how IMS Health can help pharmaceutical companies accurately assess their markets.¹ This was a marketing study that was commissioned by a company to identify a glitch in its sales forecasting. The downturn in hormone prescriptions dropped the overall volume of migraine medications by eight percent, and the company adjusted its sales forecasts accordingly.

Other, smaller studies found that migraines are more common in users of menopausal hormone replacement therapy (HRT). Among 1,909 postmenopausal women who had had a migraine in the previous year, current hormone users had 42 percent more migraines than non-users.² A Norwegian study published in 2007, of 18,323 postmenopausal women over 40, found similar results. 3 Such cross-sectional studies are “snapshots” of a population; because they only look at one time point, they can’t prove cause and effect. As the researchers noted, “Whether HRT caused headache or was used partly because of headache cannot be determined in this cross-sectional study.” ³

Hormones, you see, are sometimes prescribed to treat migraines. The relationship between estrogen and migraines is complex; both estrogen and estrogen withdrawal seem to be able to trigger migraines.⁴ But, at the time the Norwegian study was published, a data-mining company and a pharmaceutical manufacturer of a migraine drug were sitting on a larger, better, more comprehensive study. And they are still sitting on it. Why? Because data from patient records and prescription records are commissioned by marketing and sales departments. Prescribing data is purchased by and used by industry in order to market drugs, monitor sales, and keep an eye on competitive products. Public health is not a consideration.

There are undoubtedly thousands of studies commissioned by pharma marketing departments that could major public health implications. What other important public health information is industry sitting on?

REFERENCES

1. Von Allmen H, Stuchlach W, “Traveling Through Time to More Accurately Forecast Brand Performance,” Product Management Today 2006; September: 12-13.

2. Misakian AL, Langer RD, Bensenor IM, et al., “Postmenopausal hormone therapy and migraine headache,” J Womens Health (Larchmt) 2003; 12(10): 1027-36.

3. K L Aegidius, Zwart JA, Hagen K, “Hormone replacement therapy and headache prevalence in postmenopausal women: The Head-HUNT Study,” European Journal of Neurology 2007; 14(1): 73-78.

4. Brandes JL, “The Influence of Estrogen on Migraine: A Systematic Review,” JAMA 2006; 295: 1824-1830.

Adriane Fugh-Berman, M.D., is an associate professor in the Georgetown University School of Medicine, Dept. of Physiology, and a former chairof the NWHN.