Monthly Archives: May 2012

FDA outpaces its global peers at drug reviews

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The US Food and Drug Administration is often criticized for taking a plodding approach to drug regulation. But when it comes to approving novel therapeutics, the agency is actually much speedier than its European and Canadian counterparts.

“Many of the criticisms that the FDA has been facing over the past couple years were not based on concrete data,” says Jeff Allen, executive director of Friends of Cancer Research, an advocacy organization based in Washington, DC. “Hopefully this will let people really focus on the challenges facing drug regulation, rather than falling into talking points about approval speed.”

Using publically available records, a team from the Yale University School of Medicinein New Haven, Connecticut compared the review times of all small molecule and biologic drugs approved by the FDA, the European Medicines Agency (EMA) and Health Canada from 2001 through 2010. Reporting online today in the New England Journal of Medicine, the researchers found that, regardless of drug type, orphan designation or priority review status, the FDA cleared new medicines, on average, at least a month faster than the other two agencies (see chart).

“Pretty consistently the FDA was coming out on top,” says Yale medical student Nicholas Downing, who led the work. For example, when considering just the 72 agents approved by all three regulators, the median review time at the FDA was a full three months shorter than at the other agencies—under nine months at the FDA, compared to almost a year at the EMA and Health Canada .

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Pharma backs latest attempt at a global health R&D treaty

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The World Health Organization (WHO) kicks off its annual meeting in Geneva next Monday, and one of the most contentious issues on the agenda will undoubtedly be a proposed agreement to fund the development of drugs for diseases that overwhelmingly afflict the world’s poor. The proposal, outlined today in PLoS Medicine, would require the WHO’s 193 member states to commit to increase government funding for global health initiatives from the $3 billion or so spent worldwide today to more than $6 billion annually in the near-future.

To raise that money, the authors of the report, which include global health economists, industry executives and patent experts from the WHO’s Consultative Expert Working Group on Research and Development (CEWG), call for every member nation to contribute at least 0.01% of its gross domestic product (GDP) for research and development (R&D) into neglected diseases—a percentage currently paid by only one country: the US.

“Money is the new focus of this debate,” says James Love, an advocate for affordable medicines and director of Knowledge Ecology International, a social justice nonprofit based in Washington, DC. “Now that it’s about funding, governments have to start talking to each other.”

Importantly, big pharma appears to be on-board—which may pave the way for successful passage of the treaty at next week’s World Health Assembly. “We’re hearing from industry a need to reform the current system,” says CEWG chair John-Arne Røttingen, a health economist at the University of Oslo’s Institute for Health and Society who coauthored the report. Similar proposals were put forward by coalitions of member states and non-governmental organizations in 2005 and 2009, but both efforts failed to even make it to a vote after drug companies lobbied hard against proposed patent reforms that would have opened the door to more generics for a wide variety of medicines. In contrast, the current draft treaty only calls for less patent protection of treatments for diseases commonly found in the developing world, such as malaria, Chagas disease and dengue fever.

Paul Herrling, head of corporate research at Basel-based Novartis and a member of the CEWG, also notes that the proposed convention includes some incentives for the pharmaceutical industry. For example, it aims to arrange sustainable financing for companies to further develop early-stage products for neglected and tropical diseases that the firms already have in their pipelines. “Industry is willing to contribute resources to early stage R&D,” Herrling says. “But to bring those products all the way to the market, they need more than private donors can give.”

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One in six cancer cases are caused by preventable infection, study finds

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You can’t catch cancer, or so many think. Cancer is considered a non-communicable disease by the World Health Organization, but among cancer’s many causes are viruses that can travel from person to person, and, if infection persists, lead to tumor growth. For example, the human pappilomavirus (HPV) often triggers cervical, anal and other cancers, which has prompted public health agencies to push mass vaccine campaigns for boys and girls alike (see ‘The value of HPV vaccination’).

The importance of making such prevention available around the world was made startlingly clear today in a study published online in The Lancet Oncology, which estimates that of the 12.7 million new cases of cancer in 2008, fully 16% were caused by infections. The vast majority of those cancer cases were caused by one of four pathogens: HPV, Helicobacter pylori and the hepatitis B and C viruses. Although infections by all these pathogens can be prevented with vaccines or treated with simple antibiotics, they nonetheless caused close to 2 million cases of gastric, liver and cervical cancer.

Today’s findings point to “a very large potential for cancer prevention by preventing infectious causes of cancer,” Goodarz Danaei, an epidemiologist at the Harvard School of Public Health in Boston who wrote an accompanying commentary, told Nature Medicine.

To determine the role of infection in causing cancer worldwide, the paper’s authors analyzed incidence, prevalence and mortality data for 27 cancers in 184 countries. Senior author Catherine de Martel says the findings published today are particularly important for developing countries, where approximately 25% of cancers are caused by infection. The most severely hit, the authors found, was sub-Saharan Africa, where nearly 1 in 3 cases of cancer are caused by preventable or treatable infection.

“This study highlights the need for cancer control priorities to be set in light of the burden of infection-related cancers, particularly in the low- and middle-income countries,” says de Martell, an epidemiologist at the International Agency for Research on Cancer in Lyon, France.

Artist’s rendering of HPV courtesy of Michael Taylor via Shutterstock

Another drugmaker abandons plans to boost ‘good’ cholesterol

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There’s bad news out today for ‘good cholesterol’ drugs. More than five years after New York’s Pfizer made waves for pulling the plug on torcetrapib—a drug designed to elevate blood levels of high-density lipoprotein (HDL), or ‘good’ cholesterol—Roche is now making a similar move.

The Swiss pharma giant announced plans to halt development of its own HDL-raising compound, dalcetrapib, after an interim independent review of the company’s pivotal 15,000-person trial found no signs of clinically meaningful efficacy. Unlike torcetrapib, which was linked with an increased risk of heart attacks, no problematic safety signals were detected for dalcetrapib. “We are disappointed by the fact that this drug didn’t provide benefit to the patients in our study,” Hal Barron, Roche’s chief medical officer, said in a statement.

As we reported last July, studies of various drugs have cast doubt on the idea that raising HDL cholesterol levels will translate into robust clinical benefits for patients.

There are still some experts holding out hope, though. Robert Rosenson, director of cardiometabolic disorders at the Mount Sinai Heart Institute inNew York, thinks that other HDL modulators in clinical testing—including Merck’s anacetrapib and Eli Lilly’s evacetrapib—could hold therapeutic promise. “It would be a mistake to close the door on this class of compounds,” he says. “I don’t believe that the failure of dalcetrapib will mean that these agents are not going to be efficacious in the right populations.”

 

‘The Vagina Catalogues’ show a microbiome in flux, sometimes daily

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When the vaginal microbiome gets out of whack, it causes an uncomfortable, often chronic condition known as bacterial vaginosis, which is associated with pregnancy complications such as premature birth as well as a heightened risk of contracting sexually transmitted diseases. But finding ways to return the disrupted vaginal microbiome to its normal, healthy state has proven difficult because nobody knows what ‘normal’ really means.

As Nature Medicine reported in a July 2011 news feature, a team of scientists at the University of Maryland School of Medicine in Baltimore had found that there are many naturally occurring versions of the microbiome, in part because the bacteria present in a woman’s vagina may vary according to her ethnicity. In a paper published today in the journal Science Translational Medicine, the same team goes on to show that although ethnicity can predict the make up of a the vaginal microbiome over a lifetime, in individual women this bacterial community can change dramatically within a matter of days—often without causing any effects on health.

To characterize this microbial variability, the scientists recruited 32 healthy volunteers for a labor-intensive study. The women enrolled, half of whom were black and half of whom were white, self-sampled vaginal swabs twice a week for more than three months and sent them off to the lab of lead author Jacques Ravel and his collaborator, Larry Forney of the University of Idaho in Moscow. There, biologists sequenced the genomes of the bacteria present in the samples to determine the relative abundance of, for example, the common bacteria species Lactobaccilus or Anaerococcus. For each woman, a picture emerged of a unique and surprisingly mercurial bacterial community. “There has been an assumption that microbiomes are stable over time,” says Forney. “But we found that over the course of just a few days, the entire microbial community could change in a given woman.”

These findings could help biologists develop personalized treatments for bacterial vaginosis, yeast infections and other conditions in which the microbiome is disturbed. “Right now, the antibiotic and probiotic treatments that exist for these diseases work for some women but not for others, and that’s because we don’t understand the environment we’re trying to treat,” says Forney. The hope, he and his colleagues say, is that these findings will lead to new treatments tailored to specific groups of women.

To move toward that goal, they have already begun enrolling more than 160 women to take daily vaginal samples for a larger, more rigorous study of how the various ‘normal’ microbiomes they identified in today’s paper change when a healthy woman develops a vaginal infection. “We need to start rethinking the idea of personalized treatment for diseases of the vagina,” says Ravel.

To read ‘The Vagina Catalogues’ click here.

Artwork by Alyssa Grenning