ScienceInsider

by Sam Kean

The drug companies Pfizer and Parke-Davis (now a subsidiary of Pfizer) shaded clinical trial results in at least 12 studies in order to make the drug gabapentin appear more effective for off-label use, says a report today in The New England Journal of Medicine.

by Dennis Normile

Not surprisingly, cancer researchers in Asia think their specialty deserves to be a higher global health priority. Today at an Asia Cancer Forum discussion in Tsukuba, Japan, one speaker after another pointed to statistics showing that cancer, though thought of as an advanced country scourge, is rapidly overtaking AIDS, tuberculosis, and malaria as a cause of premature mortality in the developing world. Yet cancer isn’t mentioned as one of the United Nations Millennium Development Goals. Shigeru Omi, former World Health Organization Regional Director for the Western Pacific now at Jichi Medical University in Tochigi Prefecture, drew murmurs of approval from the partisan crowd when he said the global health pendulum had swung too far towards addressing infectious diseases "at the expense of non-communicable diseases." He suggested that Japan use its influence with international organizations to rebalance priorities.

by Jon Cohen

Concern appears to be rising at the U.S. Centers for Disease Control and Prevention about people in lower risk groups cutting in line to receive the limited supplies of H1N1 vaccine. A letter sent today from CDC Director Thomas Frieden to state and local health officers urges that the 35.6 million doses of the vaccine now available first go to people at the highest risk of developing severe disease from the pandemic virus. Although the letter does not detail any specific problems, it pointedly says, “vaccine distribution decisions that appear to direct vaccine to people outside the identified priority groups have the potential to undermine the credibility of the program.”

by Jon Cohen

With reporting by Martin Enserink.

Although the world’s attention is focused on the novel H1N1 virus causing the swine flu pandemic, H3N2, a seasonal strain of influenza, has popped up in many East Asian countries—and some variants in circulation may outfox the seasonal vaccine in use. “We have seen that H3N2 viruses have been in fairly broad circulation in some of the countries there,” Keiji Fukuda, special adviser on pandemic to the director-general of the World Health Organization, said at a press conference today.

The H3N2 strain is one of three in the seasonal influenza vaccines. But if the H3N2 strain in circulation differs substantially from the one used to make the vaccine, the vaccine may offer less protection, and more people will get sick than usual. “For the current H3N2, we don't have such studies, so I can't tell you right now the degree the current seasonal vaccine will protect against the H3N2 virus,” Fukuda says.

by Jocelyn Kaiser

Fewer academic biomedical scientists are relying on industry support for their research than in the mid-'90s, according to a study highlighted today in The Boston Globe. That's the most surprising result of the latest survey of industry relationships at universities led by conflicts of interest expert Eric Campbell of the Massachusetts General Hospital. Campbell and his co-workers found that 20% of the more than 2000 life sciences faculty who responded in 2007 have direct industry funding, according to a paper in Health Affairs. That's down from 28% in a 1995 survey.

In a press release, the authors point to the growth of the National Institutes of Health budget and level research funding in industry as possible factors—as well as a growing public uproar about drug company payments. “Industry relationships may be declining because of increased regulation by universities as well as a general attitude among the public that working with industry is somehow bad,” Campbell says.

One of Campbell's longstanding messages hasn't changed: Industry relationships are pervasive in academic biomedicine.

by Martin Enserink

It's a promise: 10% of the 250 million doses of H1N1 vaccine purchased by the United States will be donated to help poor countries. But when is still unclear. At a press conference today, Thomas Frieden, head of the U.S. Centers for Disease Control and Prevention, declined to answer questions about the timing of the gift. "That has to be determined as the production schedule will become more clear in the weeks to come."

WHO expects to send some 200 million doses of vaccines donated by countries and governments to the developing world. Timing is key, because the vaccine will do the most good if it's used before a wave of infection peaks. As WHO's Marie-Paule Kieny just told ScienceInsider, the United States has promised the first part of its share of 25 million doses by early December.

But AFP suggested last week that the United States will not donate any vaccine until it has taken care of the 159 million people in its priority groups.

by Martin Enserink

As the H1N1 swine flu pandemic marches on, western countries have begun vaccinating their most vulnerable populations against the virus. But many countries in the developing world lack the resources to buy the vaccine. With charitable donations from manufacturers and rich countries, the World Health Organization is trying to get cash-strapped countries at least some vaccine. Marie-Paule Kieny, head of WHO's Initiative for Vaccine Research, gave ScienceInsider an update on how this complex operation is moving along. Questions and answers have been edited for brevity and clarity.

Q: At a press conference last week, you said that WHO's plan to distribute vaccine to the developing world is now moving into its operational phase, and that WHO Director-General Margaret Chan has approved a list of 95 countries eligible for vaccine donations. Can we get a list of those countries?

M.-P.K.: No, because some of those countries may decide not to get the vaccine. So far, only about 40 countries have sent us a letter of intent saying they want us to send vaccine. Before we can make the names of the eligible countries public, we must know that they are willing to accept the conditions.

Q: What are those conditions?

M.-P.K.: They have to sign an agreement that they hold the vaccine manufacturers harmless in case of adverse events. WHO cannot bear that responsibility, so we're passing it on to the governments. It's the same as for most developed countries; they had to agree to this as well.

Q: Are the developing countries reluctant to accept that liability?

by Greg Miller

Can a genetic disorder that derails brain development be cured with a drug? A clinical trial announced today represents the first step towards testing a drug therapy for Fragile X syndrome, the most common inherited cause of intellectual disability. The trial will enroll healthy volunteers and assess the safety of a drug that blocks a type of glutamate receptor thought to be overactive in people with Fragile X. Experts have long assumed that once the brain is wired wrong during development that it can't be fixed by simply giving someone a drug.

by Jon Cohen

U.S. policymakers erred on the side of caution in September when they recommended that children under 10 need two doses of the swine flu vaccine to develop a strong enough immune response to protect them from the disease. Now there’s strong evidence that they made the right call. New data also show for the first time that pregnant women need only a single shot.

At a press conference today, Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), revealed the new data about these two groups, which are at high risk of developing severe disease from the novel H1N1 virus. As he explained, the trials tested the inactivated vaccine made in 389 children under 10 and in 50 pregnant women.

NIAID on 21 September reported preliminary data from the children’s study, which analyzed immune responses 8 to 10 days after participants received the vaccine and suggested the younger age brackets would need two doses. The new data confirm the preliminary findings.

by Jon Cohen and Martin Enserink

Health officials today reiterated that the novel H1N1 virus continues to spread rapidly around temperate zones of the Northern Hemisphere, hospitalizing and killing an unusual number of children, young adults, and pregnant women. The need for vaccine and antivirals remains pressing in these countries, and demand currently outstrips supply. Confusion also still complicates efforts to treat and prevent disease.

Between 1% and 10% of people who develop swine flu require hospitalization, according to a review of the current epidemiologic data released today by the World Health Organization (WHO). The new data were discussed 27–29 October at a meeting of WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization. Up to 25% of hospitalized people are admitted to intensive care units, and between 2% and 9% die. Pregnant women make up 7% to 10% of hospitalized patients.

In a departure from official recommendations made elsewhere, SAGE announced that people regardless of age need only one dose of the H1N1 vaccine. The U.S. Centers for Disease Control and Prevention (CDC) recommends that children under 10 receive two doses. After the European Medicines Agency’s Committee for Medicinal Products for Human Use meeting 19–22 October, the agency recommended that everyone regardless of age receive two doses of the pandemic flu vaccines approved for use there. Granted, different vaccines are in use in different locales, but the differences reflect that data from clinical trials of various vaccines in a range of age brackets is still preliminary. And the dosing questions impact both the efficacy of the vaccines and their availability, given that they remain in short supply everywhere.

At a press conference held today by the CDC, its director, Tom Frieden, addressed the discrepancies about children under age 10. CDC based its decision for children under 10 to receive two doses on preliminary data from clinical trials of the vaccines being used in the United States, but he said more complete data should emerge soon. “Throughout this entire response, our approach is, look at the data and follow the data,” said Frieden.

Frieden also revealed new data about deaths in children.