Barbara Mintzes

Direct-to-Consumer Advertising of Prescription Drugs: The Evidence Says No

There is little rationale for direct-to-consumer advertising of prescription drugs. Most new drugs offer little if any therapeutic advantage over existing products. Direct-to-consumer advertisements frequently downplay safety information. Physicians are highly ambivalent about prescribing advertised drugs requested by patients. There is no evidence that direct-to-consumer advertising results in any improvement in health outcomes.

Disease Mongering in Drug Promotion: Do Governments Have a Regulatory Role?

Most regulatory agencies, says Mintzes, fail to treat regulation of drug promotion as a public health concern. Unless this changes, she says, the public can expect more unfettered disease mongering.

Overdiagnosis of bone fragility in the quest to prevent hip fracture

Despite widespread endorsement, Teppo Järvinen and colleagues argue that evidence for stratifying risk of fracture and subsequent drug therapy to prevent hip fracture is insufficient to warrant our current approach

Prescription Drug Use in Pregnancy: A Retrospective, Population-Based Study in British Columbia, Canada (2001–2006)

BACKGROUND Owing to the paucity of evidence available on the risks and benefits of drug use in pregnancy, the use of prescription medicines is a concern for both pregnant women and their health care providers. OBJECTIVE The aim of this study was to measure the frequency, timing, and type of medicines used before, during, and after pregnancy in a Canadian population. METHODS This retrospective cohort analysis used population-based health care data from all pregnancies ending in live births in hospitals in British Columbia from April 2001 to June 2006 (n = 163,082). Data from hospital records were linked to those in outpatient prescription-drug claims. Data from prescriptions filled from 6 months before pregnancy to 6 months postpartum were analyzed. Drugs were classified by therapeutic category and US Food and Drug Administration (FDA) pregnancy risk categories. RESULTS Prescriptions were filled in 63.5% of pregnancies. Evidence on safety is limited for many of the medicines most frequently filled in pregnancy, including codeine, salbutamol, and betamethasone. At least 1 prescription for a category D or X medicine was filled in 7.8% of pregnancies (5.5% category D; 2.5% category X). The most frequently filled prescriptions for category D drugs were benzodiazepines and antidepressants. The most frequently filled prescriptions for category X drugs were oral contraceptives and ovulation stimulants filled in the first trimester. CONCLUSIONS The majority of pregnant women in British Columbia filled at least 1 prescription, and ~1 in 13 filled a prescription for a drug categorized as D or X by the FDA. The prevalence of maternal prescription drug use emphasizes the need for postmarketing evaluation of the risk-benefit profiles of pharmaceuticals in pregnancy. Future research on prenatal drug use based on administrative databases should examine maternal treatment adherence and the determinants of maternal drug use, considering maternal health status, sociodemographics, and the characteristics and providers of prenatal care.

Advertising of prescription-only medicines to the public: does evidence of benefit counterbalance harm?

Since the global withdrawal of rofecoxib (Vioxx) in 2004, concerns about public health effects of direct-to-consumer advertising (DTCA) have grown. A systematic review of the research evidence on behavioral, health, and cost effects, published in 2005, found four studies meeting inclusion criteria, which showed that DTCA increases prescribing volume and patient demand, and shifts prescribing. From 2005 to 2010, nine studies met similar criteria. These largely confirm previous results. Additional effects include a shift to less appropriate prescribing, differential effects by patient price sensitivity and drug type, switches to less cost-effective treatment, and sustained sales despite a price increase. Claimed effects on adherence do not stand up to scrutiny and are based mainly on negative trials. There is no evidence of improved treatment quality or early provision of needed care. If policy is to be informed by evidence, the strength of research methods and ability to assess causality need to be considered.

The Sources and Popularity of Online Drug Information: An Analysis of Top Search Engine Results and Web Page Views

Background: The Internet has become a popular source of health information. However, there is little information on what drug information and which Web sites are being searched. Objective: To investigate the sources of online information about prescription drugs by assessing the most common Web sites returned in online drug searches and to assess the comparative popularity of Web pages for particular drugs. Methods: This was a cross-sectional study of search results for the most commonly dispensed drugs in the US (n = 278 active ingredients) on 4 popular search engines: Bing, Google (both US and Canada), and Yahoo. We determined the number of times a Web site appeared as the first result. A linked retrospective analysis counted Wikipedia page hits for each of these drugs In 2008 and 2009. Results: About three quarters of the first result on Google USA for both brand and generic names linked to the National Library of Medicine. In contrast, Wikipedia was the first result for approximately 80% of generic name searches on the other 3 sites. On these other sites, over two thirds of brand name searches led to industry-sponsored sites. The Wikipedia pages with the highest number of hits were mainly for opiates, benzodiazepines, antibiotics, and antidepressants. Conclusions: Wikipedia and the National Library of Medicine rank highly In online drug searches. Further, our results suggest that patients most often seek information on drugs with the potential for dependence, for stigmatized conditions, that have received media attention, and for episodic treatments. Quality improvement efforts should focus on these drugs.

Twelve years' experience with direct-to-consumer advertising of prescription drugs in Canada: a cautionary tale.

Background Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’ advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’ advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Methodology/Principal Findings Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD

Patterns of psychotropic medicine use in pregnancy in the United States from 2006 to 2011 among women with private insurance

2 million per year before 1999 to over

Too Few, Too Weak: Conflict of Interest Policies at Canadian Medical Schools

22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >

Transparency in drug regulation: Mirage or oasis?

500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Conclusions/Significance Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for compromise solutions to industry pressure for expanded advertising, Canadas experience stands as a stark warning.