Publications

OBJECTIVES

To understand the competition between and among tobacco companies and health groups that led to graphical health warning labels (GHWL) on all tobacco products in India.

METHODS

Analysis of internal tobacco industry documents in the Legacy Tobacco Document Library, documents obtained through India's Right to Information Act, and news reports.

RESULTS

Implementation of GHWLs in India reflects a complex interplay between the government and the cigarette and bidi industries, who have shared as well as conflicting interests. Joint lobbying by national-level tobacco companies (that are foreign subsidiaries of multinationals) and local producers of other forms of tobacco blocked GHWLs for decades and delayed the implementation of effective GHWLs after they were mandated in 2007. Tobacco control activists used public interest lawsuits and the Right to Information Act to win government implementation of GHWLs on cigarette, bidi and smokeless tobacco packs in May 2009 and rotating GHWLs in December 2011.

CONCLUSIONS

GHWLs in India illustrate how the presence of bidis and cigarettes in the same market creates a complex regulatory environment. The government imposing tobacco control on multinational cigarette companies led to the enforcement of regulation on local forms of tobacco. As other developing countries with high rates of alternate forms of tobacco use establish and enforce GHWL laws, the tobacco control advocacy community can use pressure on the multinational cigarette industry as an indirect tool to force implementation of regulations on other forms of tobacco.

OBJECTIVES

Despite advances in systemic lupus erythematosus (SLE) treatment, many patients suffer from the disease and side effects. Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand, which are increased in patients with SLE.

METHODS

In this double-blind, placebo-controlled study, patients with moderate-to-severe SLE were randomised to atacicept 75 mg or atacicept 150 mg administered subcutaneously, or placebo twice-weekly for 4 weeks, then weekly for 48 weeks. Primary and secondary efficacy measures were the proportion of patients experiencing at least one flare of British Isles Lupus Assessment Group A or B, and time to first flare, respectively.

RESULTS

Enrolment in the atacicept 150 mg arm was discontinued prematurely due to two deaths. In the intention-to-treat population (n=461), there was no difference in flare rates or time to first flare between atacicept 75 mg and placebo. Analysis of patients treated with atacicept 150 mg suggested beneficial effect versus placebo in flare rates (OR: 0.48, p=0.002) and time to first flare (HR: 0.56, p=0.009). Both atacicept doses were associated with reductions in total Ig levels and anti-dsDNA antibodies, and increases in C3 and C4 levels. Most treatment-emergent adverse events were mild or moderate.

CONCLUSIONS

There was no difference between atacicept 75 mg and placebo for flare rate or time to first flare. Analysis of atacicept 150 mg suggested benefit.

TRIAL REGISTRATION NUMBER

EudraCT: 2007-003698-13; NCT00624338.