Almost any day of the week in Washington, DC you can go to a public hearing—and if you’re lucky you’ll be entertained at the sight of some harried public servant squirming under the relentless questioning of our elected representatives. Last week’s intended victim was Andrew von Eschenbach, head of that beleaguered agency, the US Food and Drug Administration.

Von Eschenbach appeared before Senate and House appropriations subcommittees to defend the proposed 2008 FDA budget. On Wednesday I wandered down to the capitol—source of straitjacket dull fashion and casualty of a recent impertinent smoking ban, courtesy of Nancy Pelosi—to check out the action at the House.

I have to admit that I should have taken better notes. But every time von Eschenbach opened his mouth I wanted to fall asleep; he must have used the word “system” about 18 times and “process” at least 22.

Still, I woke up when representatives began grilling von Eschenbach about news reports that he planned to cut funding for the FDA’s Office of Women’s Health—ostensibly in retaliation for the office’s support for over-the-counter “Plan B” contraception.

He called the reports, “inaccurate.” but he failed to assuage the committee, saying, “I haven’t made that decision yet.” Congress will have to wait till March 15 to learn if funding will be retained. I must admit I was a bit disappointed: He obviously wasn’t squirming enough.

Von Eschenbach also faced a phalanx of representatives concerned about food safety. He could not say when a long-overdue report on this summer’s spinach outbreak would appear, had no opinion on whether irradiation was underused to zap food, and I'm still not sure what he would do if he was, hypothetically, given $20 million more for food safety. But he did use one of those words again. How to shore up the food supply? “This is a systems problem that requires a systems approach.”

Representative Sam Farr from California’s spinach district was not impressed, “It’s a mystery why they [the FDA] would come before us with so few concrete answers,” he said in a press release.

Committee members also did not let von Eschenbach off lightly when it came to drug safety, grilling him about the approval of the antibiotic Ketek—itself a subject of separate hearings. Von Eschenbach defended the FDA’s record on conflict of interest among members of its advisory committees, saying it was broadening access to experts and that the agency “Is taking a process improvement approach to this.”

The committee’s chair, Rosa DeLauro from Connecticut, seems like the smartest of the bunch, bristling with sharp questions and a record of sponsoring a measure to grant the agency greater authority over post-marketing surveillance.

She and other committee members could be strong advocates for positive change at the FDA, especially if von Eschenbach begins to work better with the congressmen who have authority over his budget. Now that’s a process worth improving.

Posted by Charlotte Schubert at 04:32 PM | Permalink | Comments (0)

The Scientist recently published a "Guide to retractions" written by Andrea Gawrylewski.

She makes a good point that there has been a proliferation of terms to create awareness that something's not right about a paper. "Expression of Concern Reaffirmed"? That's one I hadn't heard before.

In our neck of the woods, I'm embarrassed to say that we are rather old fashioned. We only have Addenda, Corrigenda, Errata and Retractions (which, for consistency, we should start calling 'Retracta', I guess).

I suspect that this paucity of terms will be a bit disappointing to some of our readers, particularly to those who write to alert us that someone committed some form of misconduct that invalidates the conclusions of a paper and then discover that we didn't even "express our concern", let alone reaffirm it.

This is not to say that we don't care when someone lets us know that a paper may have fraudulent data. But the reality is that many of the allegations we receive are not documented at all and/or are anonymous. In other words, it's hard to take seriously an e-mail saying:

"Please be aware that the paper by Hornmeister et al. is the result of scientific fraud.

Sincerely yours,

A friend of Nature Medicine"

Sometimes, people accuse colleagues of what one could call 'fraud by proxy':

"Please be aware that the paper by Hornmeister et al. that you are currently considering may be the result of scientific fraud, as he has a paper under investigation at another journal.

Sincerely yours,

Another concerned friend of Nature Medicine"

It's then amusing to discover that, roughly half the time, we are not even considering a paper by Dr. Hornmeister.

Retracting, expressing concerns or writing an editor's warning about a paper is a serious matter, not only for the authors, but also for the journal that published the work. Of course, all of us want to get the scientific record straight, but I don't think that making ill-documented, anonymous accusations is a good beginning. We have previously published in the journal suggestions about what to do when you suspect someone has committed fraud. If I'm not mistaken, throwing the stone and then hiding around the corner was not one of them.

We welcome your "expressions of concern", but please back them up with evidence and be prepared to stand behind them. As long as we continue receiving vague accusations from "friends of Nature Medicine", Dr. Hornmeister can continue to sleep peacefully.

Posted by Juan Carlos Lopez at 10:39 AM | Permalink | Comments (2)

Can the US government compel non-governmental organziations (NGOs) to condemn prostitution?

Yes, if those NGOs want to qualify for government funds. That's the upshot of a ruling on Tuesday by a federal appeals court.

Since 2003, the US has required that to qualify for funds from the $15 billion PEPFAR program for AIDS, nonprofit groups abroad have to explicitly oppose prostitution and sex trafficking.

NGOs say that taking an explicit antiprostitution stance would make it harder for them to work with sex workers, one of the highest risk groups for HIV infection. In 2005, Brazil refused $40 million from the US rather than comply with the requriements.

Even within the US, the law has been controversial and has gone through a long process of rulings and counter-rulings.

In 2005, after the law expanded to include US groups, DKT International, a Washington D.C-based organization, sued the government, arguing that the law violated its free speech rights.

Last year, a lower court agreed and ruled that the law is unconstitutional. But on Tuesday, US Circuit Judge A Raymond Randolph reversed that ruling, saying that the US Congress has authorized the Bush administration to fund these groups "on such terms and conditions as the President may determine."

What do you think? Are these acceptable strings?

Posted by Apoorva Mandavilli at 04:05 PM | Permalink | Comments (4)

As I've written before, circumcision is gaining currency as an effective means of preventing HIV. Data published in last week's Lancet suggests that circumcision cuts the risk of HIV infection by up to 65%, more even than the previous estimates.

The World Health Organization is hosting a conference in early March to make recommendations on implementing circumcision for preventing AIDS. But judging from comments here and elsewhere, it's going to be a tough sell.

Experts have warned that unsafe circumcision can endanger lives. A new study, published in the March issue of the Annals of Epidemiology, adds that in some African countries, circumcised boys are two to three times more likely to be infected with HIV. This may be because circumcision is often done with unsterilized equipment and can pass on infected blood from one child to another.

Posted by Apoorva Mandavilli at 02:57 PM | Permalink | Comments (0)

Something strange--and embarassing--has happened in India.

For the past few weeks, Novartis has been fighting a lawsuit in India that could affect the availability of cheap drugs worldwide. The lawsuit challenges India's decision to interpret WTO rules and only honor patents on drugs that are entirely new, not just derivatives or variations of existing drugs.

This clause allows Indian companies to make cheap copies that they then sell all over the world. The case is still being heard, although high-profile voices, including nonprofit group MSF (Doctors Without Borders) and Henry Waxman, chair of the influential US House Committee on Oversight and Government Reform, have asked Novartis to drop the suit. More than 250,000 people have signed the MSF petition.

In the meantime, the Indian government had asked a high-level committee, including R.A. Mashelkar, who retired last year as Director General of India's Council of Scientific and Industrial Research and is arguably one of the most respected Indian scientists, to look into the patent issue. After nearly two years' deliberations, the committee produced a report on the law that is favorable to Novartis.

But get this: an Indian newspaper discovered that the crucial bits of the report were plagiarized from a paper published by a think tank in the UK and funded by INTERPAT, an association of pharma companies whose members include Novartis. Mashelkar says he didn't know about the plagiarism and has withdrawn the report, asking for three months to review it. I buy that he didn't know about the plagiarism and that it might have crept in when the "draft was being worked on by a sub-group" but the larger issue is the potentially biased source of the original conclusions.

The government hasn't yet said whether it will accept the revised report, but any way you slice it, this is a deeply embarassing incident for Indian science. Earlier this month, Nature challenged Indian scientists to speak up and help shape policies. This is an inauspicious start indeed.

Posted by Apoorva Mandavilli at 05:59 PM | Permalink | Comments (1)

Our former intern Emily Waltz points out that Scientific American's March issue has given Francis Collins and Anna Barker, who lead the Cancer Genome Atlas initiative, several pages to, as Emily puts it, "make their case" for the project.

The cancer genome atlas, which is supposed to catalog all the mutations found in human cancers, is ambitious in scope--it's expected to cost about $1 billion over the next decade. Just the pilot phase, which began a year ago, has a tab of $100 million. That's no small sum when individual researchers are feeling the pinch of tightening budgets.

Emily is understandbly skeptical. Her reporting of the project last year uncovered serious practical hurdles facing the project, including the lack of enough tumor samples with the required informed consent. Privately, many scientists also complain that this is a vanity project and is unlikely to do much beyond run up masses of data.

As if in direct response to that criticism, Collins and Barker say, "Piles of data are, of course, not worth much without evidence that comprehensive knowledge of cancer's molecular origins can actually make a difference in the care of people."

Collins and Barker are right to note that drugs like Gleevec, which is what scientists like to call a "rational drug," can result from identifying the molecular origins of a cancer. But the article isn't really clear on how the project is likely to deliver those drugs--at least, not enough to make it worth the hefty price tag.

Posted by Apoorva Mandavilli at 03:08 PM | Permalink | Comments (0)

The prominent Chinese AIDS activist Gao Yaojie, whom I blogged about previously, left Beijing yesterday to receive an award in Washington DC for her work exposing blood-selling schemes that infected tens of thousands. Chinese authorities had released her from house arrest, suggesting that they respond to international media coverage and diplomatic pressure.

But what about AIDS activists who are not so internationally famous? How are they faring? To find out, I called up Nicholas Bequelin, a Hong-Kong based researcher at Human Rights Watch, which in 2003 published a report on human rights and AIDS in China.

“Essentially all the independent HIV aids activists in China operate under fairly difficult conditions,” says Bequelin, “We still see the harassment of individuals and grassroots activists.”

NGOs (nongovernmental organizations) in China have few legal protections from authorities wary of initiatives operating outside of the government framework. That’s not the most effective way to fight a virus that at current rates of transmission could infect 10 million people in China by 2010, according to estimates by the United Nations.

“I think international experience shows clearly that NGOs are the most effective groups to deal with high risk populations—sex workers, injection drug users, gay men, truck drivers—to reach them you need to have organizations that are grass roots,” says Bequelin.

As an example, consider the strong link between AIDS activism and the gay rights movement in the United States. Yet in China, the government only decriminalized homosexuality ten years ago and only six years ago removed it from a state list of mental disorders. In many parts of the country, people with HIV/AIDS are still stigmatized.

Over the last several years, China has improved its approach to AIDS treatment and prevention, for instance, increasing spending and applying for funds from the Global Fund to Fight Aids, Tuberculosis and Malaria. Yet the country still has a long way to go.

The 2003 report from Human Rights watch extensively documents the harassment and surveillance of groups that combat HIV/AIDS. Much of that is still going on, says Beqeuelin, who provided two examples:

1. Wan Yanhai, the director China’s leading AIDS NGO, Aizhixing, was reportedly coerced into canceling a conference on HIV-AIDS and human rights. The conference, “Blood Safety, AIDS and Legal Human Rights” was to have taken place in Beijing in November, 2006. But Yanhai called off the conference after being detained by Beijing security personnel for two days.

2. In Tianjin, police harassment has curtailed advocacy and awareness projects in clubs and other places where gay people meet. In July 2006, the police arrested clients at a male bath house and confiscated all the condoms supplied by Tianjin’s Family Planning Association, according to reports from Aizhixing. A month later police again raided the club. “Everything has disappeared in the city,” says Bequelin, “There are no activities in terms of prevention and awareness for gay men.”

Even Yaojie has said she is wary of being too outspoken during her trip to the United States.

The 1980's AIDS activist slogan "Silence=Death" was powerful for a reason- this is a virus that thrives on silence.

*****
By some estimates, a billion people watched the Academy awards last Sunday—and surprisingly that could provide a boost to efforts to publicize the fate of individuals infected with HIV through tainted blood in China. The documentary “The Blood of Yingzhou District" won the award for best documentary short subject. The film, produced by the China AIDS Media Project follows the life of a child orphaned by the blood scandal. The film will be playing in mid-March here in DC and I’ll be blogging about it later.

Posted by Charlotte Schubert at 11:15 AM | Permalink | Comments (0)