Opinion in 2012

In recent years, the pharmaceutical industry has struggled to deliver new therapies, especially for diseases that affect the most vulnerable in developing countries. The global health community can fill this vacuum by catalyzing innovative partnerships across academia, government and the private sector, fostering a more rigorous environment for scientific decision making and creating the tools and infrastructure to conduct effective translational research.

Clinical trials typically address more than one question. But in attempting to protect against misleading results that are due to chance when multiple interrelated tests are run simultaneously, researchers sometimes apply overly strict statistical devices that mask true effects. They should give more consideration to choosing the type of statistical analysis that fits best.

Doctors and regulatory agencies rely on meta-analyses when setting clinical guidelines and making decisions about drugs. However, as the number of these analyses increases, it's clear that many of them lack robust evidence from randomized trials, which may lead to the adoption of treatment modalities of ambiguous value. Without a more disciplined approach requiring a reasonable minimum amount of data, meta-analyses could lose credibility.

The compulsory license mechanism is broken and will not bring drug access to the world's poorest nations. It's time to consider another option—a tax levied on patents—to fund drugs for developing countries, rather than the erratic compulsory licensing mechanism.

The Recombinant DNA Advisory Committee, formed in 1974, was originally charged with advising on potential risks of recombinant technology and took on review of clinical gene therapy protocols in the late 1980s. But as gene therapy has made headway with safety, it's time to shift the committee's mission toward broader ethical and technical issues linked to the field.

In the run-up to his reelection, Russian president Vladimir Putin outlined 28 tasks to be undertaken by his administration, including one that commanded the development of weapons based on “genetic principles.” Political pressure must be applied by governments and professional societies to ensure that there is not a modern reincarnation of the Soviet biological warfare program.

The World Health Organization (WHO) is facing an unprecedented crisis that threatens its position as the premier international health agency. To ensure its leading role, it must rethink its internal governance and revamp its financing mechanisms.

In the US, states anxious to establish genetic rights are acting in the absence of clear, informed leadership. The result is specious legislative language and conflicting proposals that create confusion and disrupt genetic research and healthcare activities. It's time to look beyond our state and national borders for guidance.

Given the current challenges in research and development, it's increasingly apparent that collaboration between large pharmaceutical companies, academic teams and biotechnology enterprises is essential for converting basic biomedical discoveries into lifesaving medicines. But these partnerships work best when a neutral third party helps foster them.

The long-term decline in the number of UK doctors who conduct research is well recognized. Although some signs of recovery have been noted in the last few years, government budget cuts and the imminent rise in the tuition fee cap may make a bad situation worse.

In the US, science has increasingly taken a backstage to politics in policy decisions. But as the country enters the presidential primary season this month, one of the most counterintuitive but effective ways for researchers to make a difference may be to join the GOP.