Background

While there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.

Methodology/Principal Findings

We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).

We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.

Conclusions/Significance

Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry.

Background

Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use.

Methodology/Principal Findings

Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use.

Conclusions/Significance

Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms.

Background

Many patients’ and consumers’ organizations accept drug industry funding to support their activities. As drug companies and patient groups move closer, disclosure become essential for transparency, and the internet could be a useful means of making sponsorship information accessible to the public. This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceutical companies, focusing on their websites.

Methodology/Principal Findings

Patient and consumer groups were selected from those stated to be sponsored by a group of pharmaceutical companies on their websites. The websites were examined using two forms with principal (name of drug companies providing funds, amount of funding) and secondary indicators of transparency (section where sponsors are disclosed, update of sponsorship). Principal indicators were applied independently by two reviewers to the patient and consumer groups’ websites. Discordances were solved by discussion. One hundred fifty-seven Italian patient and consumer groups and 17 drug companies were considered. Thirteen drug companies (76%) named at least one group funded, on their Italian websites. Of these, four (31%) indicated the activities sponsored and two (15%) the amount of funding. Of the 157 patient and consumer groups, 46 (29%) named at least one pharmaceutical company as providing funds. Three (6%) reported the amount of funding, 25 (54%) the activities funded, none the proportion of income derived from drug companies. Among the groups naming pharmaceutical company sponsors, 15 (33%) declared them in a dedicated section, five (11%) on the home page, the others in the financial report or other sections.

Conclusions/Significance

Disclosure of funds is scarce on Italian patient and consumer groups’ websites. The levels of transparency need to be improved. Disclosure of patient and consumer groups provided with funds is frequent on Italian pharmaceutical companies’ websites, but information are often not complete.

Background

At the same time as there is increasing awareness in medicine of the risks of exaggerating differences between men and women, there is a growing professional movement of ‘gender-specific medicine’ which is directed towards analysing ‘sex’ and ‘gender’ differences. The aim of this article is to empirically explore how the concepts of ‘sex’ and ‘gender’ are used in the new field of ‘gender-specific medicine’, as reflected in two medical journals which are foundational to this relatively new field.

Method and Principal Findings

The data consist of all articles from the first issue of each journal in 2004 and an issue published three years later (n = 43). In addition, all editorials over this period were included (n = 61). Quantitative and qualitative content analyses were undertaken by the authors.

Less than half of the 104 papers used the concepts of ‘sex’ and ‘gender’. Less than 1 in 10 papers attempted any definition of the concepts. Overall, the given definitions were simple, unspecific and created dualisms between men and women. Almost all papers which used the two concepts did so interchangeably, with any possible interplay between ‘sex’ and gender’ referred to only in six of the papers.

Conclusion

The use of the concepts of ‘sex’ and gender’ in ‘gender-specific medicine’ is conceptually muddled. The simple, dualistic and individualised use of these concepts increases the risk of essentialism and reductivist thinking. It therefore highlights the need to clarify the use of the terms ‘sex’ and ‘gender’ in medical research and to develop more effective ways of conceptualising the interplay between ‘sex’ and ‘gender’ in relation to different diseases.

Objective, Design, Setting and Participants

The objective was to investigate media influence on consumers' health related behaviours. A cross-sectional survey of randomly selected adults (18+ years) residing in the Hunter Region of New South Wales Australia was conducted. The sample was selected using a combination of the white pages and random digit dialling.

Main Outcome Measures

The proportions of respondents who recalled seeing or hearing about conditions or treatments in the media over the 12 months prior to interview (August 2009–August 2010) and their subsequent health related behaviour.

Results

Although most survey participants reported seeking health information from their doctors, around two-thirds of survey participants (551, 68.8%) recalled hearing, seeing or reading about one or more medical conditions (total = 1097 instances) in the mainstream media over the past 12 months. Almost 40% of respondents (307, 38.4%) stated that they had looked for more information about a condition as a result of hearing about it in the media, and most used the internet (269, 87.4%). More than a quarter of respondents (215, 26.9%) indicated that they had asked their doctor about a condition they had heard about in the media. Around half of those who asked their doctor (109, 50.6%) reported that their inquiry resulted in them receiving treatment, of whom almost half (53, 48.3%) reported being prescribed a medicine.

Conclusion

The survey results show that consumers become aware of medicines through traditional media and then to learn more often turn to the internet where quality of information may be poor. (252 words)

Background

There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.

Methodology/Principal Findings

We searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6–80%); research support (4–78%); equity/stock ownership (2–17%); or any COI (56–87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs.

Conclusions/Significance

There are limited data describing the high prevalence of COI among CPG authors, and only case studies of the effect of COI on CPG recommendations. Further research is needed to explore this potential source of bias.

Patient groups provide valuable support and advocacy for vulnerable people but funding the work can be difficult. Alastair Kent argues that not accepting industry money will unnecessarily limit the groups' effectiveness, but Barbara Mintzes believes that the money undermines their independence

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$2 million per year before 1999 to over $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 >$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, Canada's experience stands as a stark warning.

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.