News & Comment

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.

The path to drug approval is long, hard and often perplexing. In recent months, the US Food and Drug Administration (FDA) has promised to bolster 'regulatory science', which aims to transform its decision-making process to be more efficient, transparent and accountable. However, diverse stakeholders, including patients, drug developers and the US Congress, will have to rise to the challenge of coordinating their priorities if this endeavor is to succeed.

Ground-breaking science in the area of cannabinoid signaling holds great promise for new drug development, but an unintended consequence of this research has led to the emergence of an onslaught of deadly 'legal highs'. Providing public health scientists with access to laboratory resources designed to investigate emerging chemicals of concern is crucial for timely, sound evaluation of products that pose major threats to public health.

The new National Center for Advancing Translational Sciences planned for the US National Institutes of Health intends to help transform biological findings into new therapeutic products. But if taxpayer funding of risky biomedical research translates into lucrative new medicines, the public should share in the economic benefits as well.

Although the globalization of clinical trials has provided benefits to host countries, critics have focused on the rare but egregious examples of unethical practices. But large, coordinated trials by the contract research industry can encourage best practice, particularly if local countries adopt more consistent standards and oversight.

A recent serious outbreak of Salmonella linked to clinical and teaching microbiology laboratories highlights the dangers of working with laboratory pathogens—but it is probably not an isolated occurrence. Without a better system for reporting infections resulting from laboratory exposures, we risk seeing more of these types of outbreaks.

With an eye to tackling the growing problem of antimicrobial drug resistance, US lawmakers last month proposed new incentives to jump-start the ailing antibiotic industry. But the legislation as written is not likely to have the intended consequences, as it fails to adequately shield companies from competition with generic drugs. To truly entice investment and research from the drug industry, the bill needs to simplify the path to regulatory approval, provide greater protection from generic competition and aid drug companies with intellectual property extensions, tax relief and guaranteed market commitments.

The do-it-yourself biology movement has exploded in recent years, culminating in the formation of the world's first community laboratory, opened late last year. As this grassroots effort continues to grow, professional biomedical researchers stand to benefit from partnering with the legions of garage biotechnology enthusiasts.

Counterfeit drugs are a menacing and deadly problem worldwide. And incidents of such counterfeiting show no evidence of declining.