NEWS

p901 Gift of life: p902 Pulling strings: p906 Bitter battle: Do global health Several US presidents Supporters of the programs really have tried to muzzle - theory save lives? top doctors. turn violent.

Executed Chinese drug czar corrupted by system, observers say

On 10 July, six weeks after sentencing Zheng Zheng himself was accused of taking drugs will be approved by a special panel, rather Xiaoyu, the former chief of its food and drug 6.49 million yuan (US$832,000) in exchange than by any single person. Agency officials will regulatory agency, for taking bribes, China for pushing through the approvals of carry out spot checks on manufacturers. New executed him. questionable drugs. His wife and son were also chemical entities—as opposed to the copycat The shocking move was a symbol of China’s investigated and reportedly arrested for running drugs that have dominated the list of SFDA efforts to get past scandals surrounding the ‘consulting agencies’ to which the SFDA referred approvals thus far—will be given fast-track agency’s approval of counterfeit medicines that applicants. status in the approval process. have killed dozens. Coming a day ahead of the In November, one of Zheng’s former secretaries, The SFDA also plans to crack down harder announcement of new drug approval policies, Hao Heping, who headed the SFDA’s medical on those who violate the . Companies that it was also intended to signal a new era in drug equipment department, received a 15-year give false information about their drugs could safety that the government envisions. prison term for accepting bribes. On 6 July, be barred for three years from applying for new But observers in the pharmaceutical industry another former secretary, Cao Wenzhuang, was drugs. Access to information on drug approvals and elsewhere are waiting to see if the events convicted of taking 2.4 million yuan ($315,700) will be open, rather than dependent on personal that follow match the government’s ambitious to approve drugs and medical equipment. Cao connections within the agency. “Transparency is plans. was also given the death sentence, although his the enemy of corruption,” SFDA deputy director “The execution was a catharsis. Now they can punishment may be reduced to life in prison. Zhen Wu told reporters on 11 July. look forward,” says Drew Thompson, director Despite his missteps, however, Zheng “was In an attempt to make the agency’s decisions of China Studies at the Washington, DC–based trying to create a system out of chaos,” says more open, the SFDA also plans to hold press Nixon Center. Thompson, who until earlier this year served as conferences on a fixed date every month, Zheng took over the helm of the newly national director of the China–MSD HIV/AIDS in contrast with the previous custom of formed State Food and Drug Administration Partnership in Beijing, a $30 million program holding them only when there were notable (SFDA) in 1998, after having headed the State established in 2005 by Merck and the Chinese announcements. Pharmaceutical Administration for the previous Ministry of Health. That approach is truly unique in China, notes five years. The post gave him wide authority to “Zheng came in with good intentions, but Wang Ming-Wei, director of the National Center streamline the chaotic system he had inherited. he was corrupted by a bad system,” Thompson for Drug Screening in Shanghai. “They are going Zheng played the role of reformer, in part by says. to be communicating with the public about enforcing national standards for traditional The 63-year-old Zheng appealed for leniency, what really is going on,” Wang says. Chinese medicines and requiring ‘Good noting that he had confessed to the crime and Wang says his greatest concern is the “slow- Manufacturing Practice’ at all drug companies. cooperated with investigators—which, by motion” pace of the drug approval system in the But the requirement that drug makers comply Chinese law, could merit a lighter sentence—but wake of the execution. Getting approval to start a with the new standards also proved useful for to no avail. new drug trial takes between 12 and 18 months, those looking to extract bribes. Chinese authorities say the harsh sentence compared with 30 days in the US, he says. was fitting. Zheng approved six “People are panicking. [The SFDA types of medicines during his investigators] are very strict—they’ll either do tenure. One antibiotic alone nothing or they’ll reject [the drug],” he says. was reportedly to blame for ten The government will also find it challenging deaths. to come through on its promise to give more The court found that enforcing power to local offices, which Zheng Zheng “greatly undermined limited during his tenure. “But local governments the uprightness of an official don’t always have the same commitment to post and the efficiency of transparency that central government has,” says China’s drug monitoring and Thompson. “The SFDA is trying to centralize supervision, endangered public and standardize approval, but decentralize life and health, and had a very enforcement. It’s a tough formula to get right.” negative social impact.” Still, most observers say the proposed The day after Zheng’s regulations are a step in the right direction. execution, the SFDA announced “[The new system] has transparency, plans for a new system that accountability, checks and balances,” says Scapegoat? is expected to go into effect 1 Thompson. “This is new for China.”

STR/AFP/Getty Images STR/AFP/Getty October. Under the new rules, David Cyranoski, Tokyo

NATURE MEDICINE VOLUME 13 | NUMBER 8 | AUGUST 2007 899 NEWS

Africa’s HIV transmission laws based on questionable science

Faced with an AIDS epidemic that kills millions Johannesburg-based AIDS Law Project. defense lawyer, I would insist on it.” every year, countries in sub-Saharan Africa Apart from stigmatizing the disease more But the procedure is complicated and costly. are contemplating a new prevention strategy: than it already is, critics warn, the laws ignore “Scientists who are not trained in this field criminal charges. the fact that these countries may not have the couldn’t just read published reports and try to Uganda, touted as the rare success story in the resources to perform the careful genetic analysis do this on their own without having the proper region, is the latest nation to propose a law that required to distinguish the innocent from the tools,” says Michael Metzker, assistant professor would criminalize knowingly transmitting HIV guilty. of molecular genetics at the Baylor College of to another person, the country’s health minister Phylogenetic analysis helps pinpoint how Medicine in Houston. announced in June. Since 2001, Zimbabwe, closely related two isolates of HIV are. In a Genetic analysis of each HIV sample can Lesotho and Swaziland have also adopted criminal case, a virologist would obtain genetic require more than 100 sequences, with a price similar laws. sequences of the virus from both parties involved tag between $1 and $5 per sequence—no small Few say the laws do what they’re intended and compare them to sequences in a database, sum in a developing country. to: reduce the spread of HIV. “They make such as the US National Institutes of Health’s A few labs in Uganda are equipped to do lawmakers feel good, but they have very limited GenBank, or from other infected individuals in the analyses, says Maria Wawer, a professor of positive benefits for the public,” says Jonathan the community. population, family and reproductive health Berger, head of policy and research at the If the viruses appear more closely related to at Johns Hopkins University who conducts each other than they are to samples taken from research in Uganda. “But it is likely to remain too the larger population, it increases the likelihood expensive for the foreseeable future,” she says. that one person infected the other. Courts in these countries may instead rely The procedure has its limitations, however. on circumstantial evidence, raising the risk of “It doesn’t say anything about the direction of wrongful convictions. movement. It doesn’t say anything about timing. “In the absence of really clear scientific It doesn’t even really say that the transmission evidence as to who infected whom,” says Azad, took place between the two people,” says Yusef “there will too often be an assumption that those Azad, director of policy and campaigns at the categorized as undesirable by society are guilty National AIDS Trust, a UK-based advocacy of infecting other people.” group. “They both could have been infected by In 2002, UNAIDS argued against laws that a third party.” penalize HIV transmission, recommending Still, phylogenetics can exonerate the instead that responsible individuals be innocent. If the two HIV samples aren’t closely prosecuted using standard criminal laws, notes related, it’s unlikely one person could have Azad. “Any legislation which singles out HIV

Jan Dago/Liaison Jan infected the other. “The greatest power of it is for this kind of criminal sanction is breaching Crime and punishment: Genetic analysis cannot prove exculpatory,” says Gerald Learn, a microbiologist international human rights guidelines.” that one person infected another with HIV. at the University of Washington. “If I was a Cassandra Willyard, New York

UK set to reverse stance on research with chimeras UK scientists who aim to use chimeras— are fertilized by animal sperm or vice versa, have applied to create cybrid embryos as hybrid embryos containing both human will still be banned. a source of ‘human’ stem cells look set to and animal material—for their research The draft regulations are expected to be have their requests granted. are awaiting a decision that would legalize signed into law in September at the earliest. But the holdup “has cost us a good their experiments. After that, the two research groups that solid year” of research time, says Stephen In December 2006, the UK government Minger, director of the Stem Cell Biology proposed a total ban on the creation of any Laboratory at King’s College London, one hybrid embryo containing human material, of the two institutions that has submitted even for research purposes, but relented applications. after an outcry from research organizations Critics of the draft bill argue that the and political watchdogs. rules are too prescriptive, rather than being The new draft regulations, published truly permissive. in May, set out a list of techniques that “The government gives no good reason would be allowed, including the creation of why some mixtures of human and animal ‘cybrid’ embryos—which comprise human genes in early laboratory embryos should DNA implanted into an empty animal be allowed and why others should be egg—and human embryos that express banned,” says Evan Harris, a member of certain animal genes or contain animal BIOTECH/HO PHOTO/MARIA AFP the Parliamentary Select Committee on cells. ‘True’ chimeras, in which human eggs Back on track: Creation of chimeras is expected Science and Technology, which produced to be legalized in the UK in September.

900 VOLUME 13 | NUMBER 8 | AUGUST 2007 NATURE MEDICINE NEWS

Dearth of data deters new institute to evaluate global health aid

Each year, developed nations pour billions of dollars into improving health in the developing world. But has all that money accomplished anything good? A new institute is being touted as the one to answer that question, but skeptics say the available data on health is too scarce to yield meaningful analysis. “We are not simply suffering from an information shortage in global health reporting,” says Amir Attaran, professor of medicine and law at the University of Ottawa. “We are suffering from a data shortage.” Over the past five years, funding for developing-world health problems has increased dramatically. Rich nations spend more than $13 billion dollars each year to improve health in Down the drain: Is the money being poured into global health programs making a difference? their poorer neighbors. But the dearth of monitoring means that no Murray says the institute will pool existing Attaran argues that surveillance centers one has a sense of whether public health in those data from hospitals, surveys and censuses established throughout the developing world places is improving and, if so, who among those with new methods of analysis to create a more should collect numbers on public health. “Once involved should take the credit. accurate picture of global health. we get good data, then we can start doing some “The sense of urgency around needing For example, data from hospitals may not analyses in Seattle and elsewhere,” he says. to tackle existing problems where people accurately represent the population at large. “So Others say that the WHO would have been are suffering and dying tends to mean that the challenge in this area is to analyze these data better suited for the institute’s task because it has careful metrics and evaluation get put on the sets in a way that takes into account the selection more authority to ask countries for data. back burner,” says Christopher Murray, who bias problem that is pervasive,” he says. But the WHO is too actively engaged will lead the new Institute for Health Metrics But critics note that before the institute can in raising funds for and implementing its and Evaluation, housed at the University of analyze the numbers, it must first find them. own programs to be an unbiased critic, says Washington in Seattle. Murray spent several Only a few diseases in developing countries Murray. “It’s never a wise idea to have the same years at the World Health Organization (WHO) are tracked carefully and, in many nations, the group advocate for money, provide technical and as director of the Harvard Initiative for most basic data—for example, who died and assistance and implement programs—and Global Health. why—are not available. then turn around and evaluate [its] own work,” Murray says. The new institute, funded by a $105 million grant from the Bill & Melinda Gates Foundation and $20 million from the a report strongly criticizing the initial we should be able to do research on true University of Washington, also aims to evaluate proposed ban. chimeras, and then we will need new the impact of global health initiatives on The debate has also raised questions legislation,” Minger says. developing countries. about the performance of the Human The new regulations were written to Until now, says Roger Bate, an economist at Fertilisation and Embryology Authority replace the 1990 Human Fertilisation and the American Enterprise Institute for Public (HFEA), which grants licenses for embryo Embryology Act, which gave birth to the Policy Research in Washington, DC, the research in the UK. HFEA and allowed it a relatively broad effectiveness of these programs has too often The HFEA was widely blamed for fueling jurisdiction to approve or refuse new been gauged by how much money is invested, the controversy over hybrid embryos technologies. rather than by the results. by referring the cybrid applications to Critics of the draft bill say that what’s “It would be like measuring the success of a politicians, encouraging attacks by those needed is more leeway for the regulatory movie by its cost of production rather than its who want to see such work outlawed on bodies, rather than more rules about what box office receipts,” Bate says. religious grounds. researchers should or shouldn’t be allowed Closer scrutiny and oversight might improve Advocates of hybrid embryo research to do with embryos. the effectiveness of these initiatives. “Shoddy fear that, because it attempts to mark “The problem is that it’s not very performers are going to have to try to hide the out the playing field so strictly, the bill practical for parliamentarians to regulate fact that they’re failing,” Bate adds, “or change.” will cause future applications for new science,” Minger argues. “The science The institute’s first task is a review of techniques to encounter similar difficulties. moves too quickly.” childhood mortality since 1970 in every country, “Someone will have an idea about why Michael Hopkin, London scheduled for release in the fall. Cassandra Willyard, New York

NATURE MEDICINE VOLUME 13 | NUMBER 8 | AUGUST 2007 901 NEWS

Nominee for US top doc grilled on political pressure

The post of US surgeon general, the nation’s stem cell research. Carmona also testified that Church on “The Pathophysiology of Male top medical authority, has long been highly he had been ordered to mention President Bush Homosexuality.” politicized. The man seeking to be the next three times on every page of his speeches. “The Office of the Surgeon General has incumbent is finding himself on the front lines The surgeon general’s office has a history of become a morass of shameful political of the conflict between scientific evidence and facing fire for its unpopular stands. The Reagan manipulation and distortion of science,” said public opinion over issues such as embryonic administration fought C. Everett Koop’s Kennedy, the committee’s chair. Holsinger’s stem cell research and homosexuality. attempts to publicize the AIDS crisis. Joycelyn history, Kennedy went on, brought him little James Holsinger, a Duke University–trained Elders, the first surgeon general under the assurance that things would improve. scientist whom the Bush administration has Clinton administration, was forced to resign “Dr. Holsinger’s paper cherry-picks nominated as the next surgeon general, opposes after she said that masturbation is normal and misuses data to support his thesis that direct-to-consumer advertising of drugs and, in and should perhaps be taught at schools. homosexuality is unhealthy and unnatural,” 2002, vigorously fought an effort to criminalize Her successor David Satcher testified that the Kennedy said. “This blatant misuse of science stem cell research in Kentucky. Clinton administration had blocked his report gravely concerns me.” But Holsinger told a Congressional panel on on the benefits of needle exchange programs. Holsinger replied that the paper was written 12 July that he also believes in President Bush’s But the blatant interference described by for a lay audience and did not purport to meet stem cell policy—which limits federal funding Carmona, on the heels of similar allegations the standards of scientific papers published in to research using stem cell lines derived before from several other agencies, may have at last the literature. “It does not represent where I am August 2001. moved Congress into action. today,” he added. “I am in favor of doing stem cell research,” Democratic senator Edward Kennedy Holsinger’s critics include the HIV Medicine Holsinger said. “We are doing that effectively.” has introduced a bill meant to depoliticize Association, one of scores of groups that wrote The hearing came two days after three the surgeon general’s office by giving it an to Kennedy opposing the nomination. former surgeons general testified in Congress independent budget and by requiring the “If he’s presented with scientific evidence that that they had been politically pressured while nominee to be drawn from a short list prepared abstinence-only programs don’t work, will he in office. by the Institute of Medicine. continue to support them?” asks Dan Kuritzkes, Most dramatically, Richard Carmona, the In the meantime, Holsinger has faced stiff the group’s chair and director of AIDS research surgeon general from 2002 to 2006, said that criticism from several members of the Senate at Brigham and Women’s Hospital in Boston. he had repeatedly been compelled by senior committee that will decide whether to bring his A vote on Holsinger’s nomination has not yet administration officials to silence his views nomination to the Senate floor for confirmation. been scheduled, but it is unlikely to occur before and to suppress reports on issues including In particular, they focused on a 1991 paper Congress’s August recess. emergency contraception, sex education and that Holsinger wrote for the United Methodist Meredith Wadman, Washington, DC

902 VOLUME 13 | NUMBER 8 | AUGUST 2007 NATURE MEDICINE Q & A

Straight talk from... Ashok Alexander India surprised the world when it announced in July that, far from being the nation with the most cases of HIV/AIDS, it is home to 2.5 million infected individuals—fewer than half of the previous estimate. The government insists that the new figures, which are supported by UNAIDS, result from a radically improved surveillance system, a national family health survey that for the first time included HIV blood tests, and a change in the way data are analyzed. Still, India lags only South Africa and Nigeria in the size of its AIDS burden. Ashok Alexander, director of Avahan, the Bill & Melinda Gates Foundation’s Indian initiative on AIDS, and one of the survey’s sponsors, explains why the dramatically lower numbers are no reason to celebrate.

What does the new estimate mean for India’s AIDS epidemic? money, my daughter’s in college, my son needs a personal computer. At one level, this is obviously good news. But on another level, nothing The second unique thing about India is the extreme mobility of high- has changed, as far as we’re concerned. Our epidemic kills several risk groups. The sex worker you work with today may be 2,000 kilometers hundred thousand Indians every year. It destabilizes large populations. away tomorrow. That makes them a moving invisible target. I’d still use the word ‘crisis’ to describe it. Do you worry that the new numbers will make the government more The numbers are half of what they were. Do you think that’s believable? complacent? I suspect the real number of HIV/AIDS cases will actually lie somewhere The good news is that the government has allocated almost $2.9 billion between the previous estimate and the new one. I think these studies are for HIV/AIDS until 2012, which is many times what it was in the past. So as much art as science. The thing is to not get too elated or too depressed I’m not worried, at least not for the next five years. But I would say the by it, and to simply keep looking at trends. We now have the first dot on Indian epidemic has gone from terribly underfunded to, arguably, still the graph, but you usually need at least three dots to make a trend, so underfunded. it’ll be six or seven years before we get anything useful. India started at 11 cents per adult. The new amount works out to a little But every time new numbers come out, there will be a bit of an over a dollar for every adult, but even with this increase, Cambodia is still upheaval. With this study, the total sample size could have been larger, spending six times as much as us. Thailand is spending twice for example. A sample size of 102,000 has been extrapolated for India what we are spending per capita. China, with an infected as a whole. Prabhat Jha, an epidemiologist at the University of Toronto, population of 650,000, is spending colossal amounts of is coming up with a study that has a cohort of 10 million. We at Avahan money. Luckily nowhere have governments said that the are also planning to release data from the first systematic survey of high- epidemic was over and that they would stop looking at it. risk groups in India, with a sample size of 25,000. I suspect that this I am more worried about other things, which is that this controversy about numbers has not ended, it’s just begun. is probably the most stigmatized health condition. It’s the kind of stigma that makes a person disown his What are some new trends that are surfacing in the Indian epidemic? own child and do other unspeakable things One positive thing is that we now have evidence that prevention can that we read about in the papers, like people actually work. This is not a minor statement, because there are a lot being stoned to death, children being denied of people around the world who question whether HIV prevention education. You know, my own friends don’t works. For example, in Tamil Nadu state, it started at about 1.5 percent want me to talk about this; prevalence and has now come down to under 0.5 percent over a it’s not the sort of subject that “I suspect that this decade. Early data is very encouraging, that after just a few years of makes for scintillating talk at early prevention we’re seeing some impact. But the challenge is to do a cocktail party. I think that controversy about prevention at scale. means that we have to step numbers has not There are a growing number of rural infections. There is also an up our advocacy efforts to tell ended, it’s just increasing feminization of the epidemic. This is a trend that occurs when people, “Pay attention, it can an epidemic matures: earlier it’s mainly male infections, and then men affect you too.” begun.” go home and pass it to their wives. Another worrying trend is the emergence of high-risk groups that were Are there organizations that should be stepping up to fight the previously not recognized. The large population of men having sex with epidemic, but aren’t? men (MSM) and the transgenders are very often married, and their sexual I would say the whole corporate community sector and Indian business practices are particularly risky. The MSM group was not even mentioned could be very much more involved. Business supply chains could be used as a risk group in the national program until recently. We pretended that for transmitting AIDS messaging right to the rural areas and for condom we did not even have this phenomenon! But it’s a very large number. distribution. Business leaders who have great stature in our country, who are more respected than even politicians, could also speak out. None of What about hidden pockets of infection, such as housewives who the above is happening. secretly practice commercial sex? The second group that can matter a hell of a lot is Indians living abroad. This hidden nature of sex work is unique to the Indian epidemic. Unlike People who are sitting in the US with vast wealth and tremendous other other countries where you have large red light areas, here—other than resources such as business acumen, financial acumen, influence—we are in the big cities—you’ll never know who’s a sex worker. Less than ten hoping to get a few of those people involved, adopting districts, adopting percent of sex work is brothel-based work; the rest of it is home-based their home ground in India and so on. The media could also be better or street-based. Often these are the women who don’t come into the informed about what the real issues are. I’m used to meeting journalists ambit of prevention services. I’ve met many housewives who practice who know nothing. commercial sex, and some of them give very simple reasons: we need the Paroma Basu, New Delhi

NATURE MEDICINE VOLUME 13 | NUMBER 8 | AUGUST 2007 903 NEWS IN BRIEF

Timeline of events…a brief history of the important news stories this month

June 15 June 21 June 21 Circadian rhythms regulate the The World Health Organization More than 60% of people who store expression of all mammalian announces a $2.2 billion plan to embryos at US fertility clinics would genes, not just 10–15% of the genes prevent the spread of drug-resistant be willing to donate them for stem as was previously thought, new tuberculosis, including funding for cell research, according to a survey of analysis of published data reveals new labs and for medicines to treat about 2,000 infertile couples (Science, (PLoS Comput. Biol. 3, e120). drug-resistant strains. doi:10.1126/science.1145067).

June 28 June 28 June 27 Scientists derive embryonic stem cells from Use of a class of antidepressants A Kazakhstani judge convicts 21 health unfertilized eggs chemically stimulated to that includes Paxil and Prozac in workers and officials of criminal retain both sets of chromosomes, a process pregnant women slightly increases negligence for infecting more than 100 that could generate genetically matched their offspring’s risk of rare birth children with HIV, allegedly through cells for therapy (Cloning Stem Cells, defects (N. Engl. J. Med. 356, 2675– contaminated blood and equipment doi:10.1089/clo.2007.0033). 2683 and 2684–2692). (Nature, doi:10.1038/news070618–12).

June 28 July 2 July 2 Scientists succeed in turning one species The US suspends Texas A&M Scientists identify two neutralizing into another by replacing the DNA of University’s bioweapons research antibodies that protect against the Mycoplasma capricolum, a goat pathogen, after the school fails to report coronavirus that causes severe acute with DNA from the closely related that researchers there were respiratory syndrome, which killed bacterium Mycoplasma mycoides (Science, exposed to agents that more than 700 people in China in doi:10.1126/science.1144622). cause Q fever and 2002–2003 (Proc. Natl. Acad. Sci. USA brucellosis. doi:10.1073/pnas.0701000104).

July 11 July 7 Indian president Abdul Kalam HIV infection increases the risk of receives the UK’s King Charles II developing at least 20 types of cancer—far medal for furthering science in more than the 7 previously identified— India, which has more than doubled including many caused by infections, its budget for science and research suggesting that cancer risk is linked to since Kalam took office in 2002. immune suppression (Lancet 370, 59–67).

July 12 July 12 July 16 UK scientists have increased Many of the genes that control Reports of heart attacks and international collaborations a cell’s identity can initiate heart-related hospitalizations in by almost 50% in the past 10 transcription even when they individuals taking the diabetes years and now work more are inactive, suggesting that the drug Avandia tripled following with scientists in China than right signal could at any time the publication in June of an with those in any European transform one cell type into analysis linking the drug to heart country, a UK government another, US researchers say (Cell problems, an Associated Press report finds. 130, 77–88). investigation finds.

904 VOLUME 13 | NUMBER 8 | AUGUST 2007 NATURE MEDICINE NEWS IN BRIEF

June 21 June 23 June 26 Five years after the US FDA warned women The makers of vitamins, herbal pills Psychiatrists top the list of that estrogen therapy can increase their and other dietary supplements will doctors in Vermont and risk of stroke and heart attack, new analysis be required to confirm that their Minnesota who receive money reveals that the therapy is actually beneficial products are free of contaminants, from drug makers for lectures, for women in their 50s (N. Engl. J. Med. 356, the US FDA announces (Nat. Med. research and trips, The New 2591–2602). 9, 634–635; 2003). York Times reports.

June 27 June 27 David Schwartz, director of Using week-old mouse embryos, the US National Institute of researchers harvest stem cells that behave Environmental Health Sciences, almost exactly like human embryonic stem misused public funds and broke cells, providing potentially good substitutes conflict-of-interest rules, The for research on human diseases (Nature Washington Post reports. doi:10.1038/nature05972).

July 2 July 3 July 3 Canadian scientists announce the Scientists produce cloned Andrew Speaker, the American birth of the first child from an egg that sperm by injecting mouse initially diagnosed with extensively was matured in a lab, frozen, thawed, sperm into mouse eggs from drug-resistant tuberculosis in May fertilized and then implanted, a process which the genetic material had and then forcibly quarantined, is that might help women undergoing been removed, a process they instead infected with a less severe cancer treatment to later conceive (Nat. hope to replicate in humans multidrug-resistant strain of the Med. 9, 1095). within five years. bacterium, US health officials say.

July 5 July 5 July 4 Depression may stem from a single Screening embryos for genetic Abbott Laboratories agrees spot deep in the hippocampus, a abnormalities before implanting to slash the price of its point at which researchers observed them in older women reduces the antiretroviral drug Kaletra reduced electrical activity in women’s chances of having a baby, in Brazil by 35%, following depressed rats but not in rats given suggesting that screening might two years of contentious antidepressants (Science, doi:10.1126/ harm the embryos, Dutch scientists negotiations with the Brazilian science.1144400). report (N. Engl. J. Med. 357, 9–17). government.

July 18 July 18 July 19 Specialized immune cells that A low-fat, high-fiber diet An HIV-positive individual’s ‘set point’— trigger asthma also produce a does not reduce the risk of at which viral load levels off after the hormone that boosts the appetite, breast cancer recurrence, immune system starts fighting the offering a potential explanation say US researchers who infection—predicts disease progression for the link between asthma and tracked more than 3,000 and may be determined in part by genetic obesity, researchers say (Proc. women for seven years variants in three major histocompatibility Natl. Acad. Sci. USA doi:10.1073/ (JAMA 298, 289–298). complex genes (Science, doi:10.1126/ pnas.0705457104). science.1143767).

NATURE MEDICINE VOLUME 13 | NUMBER 8 | AUGUST 2007 905 NEWS FEATURE

Parents of autistic children are mounting a vicious campaign against scientists who refute the link between and autism. Virginia Hughes takes the ris ng temperature of the escalating debate.

In June 2006, on the first day of the summer refute the vaccine-autism link to endure this or socially withdrawn. In some parts of the meeting of the Advisory Committee on harassment. world, autism remains stigmatized or even Immunization Practices, more than 100 “Scientists have been vilified,” says Kevin unknown—and thus undiagnosed. protesters crowded the sidewalks outside the Leitch, an English blogger who once believed Various factors, including changes in US Centers for Disease Control and Prevention that vaccines caused his child’s autism and who diagnostic practice, special education policy and (CDC) in Atlanta. now runs a blog, Left Brain/Right Brain, that even financial incentives—some US states grant Organized by a nonprofit called Moms focuses on “autism-related .” Medicaid benefits to children labeled autistic, but Against Mercury, the mob was made up mostly not to those labeled mentally retarded—make of people who believe that thimerosal—a Mysterious origins the increase in prevalence look like an epidemic, mercury-based vaccine preservative—is No one knows what causes autism. But there says anthropologist Roy Richard Grinker, who responsible for the dramatic rise in autism over is evidence to suggest that there might be a began studying autism’s prevalence in 1994 after the past two decades. genetic component. For example, identical his daughter was diagnosed with the disorder. As , a vaccine expert who served on twins are more likely to share the diagnosis “But the current numbers can’t be compared to the committee, tried to make his way through than are fraternal twins. Simon Baron-Cohen, old ones—they’re like apples and automobiles,” the crowd, one of the protestors screamed at director of the at the he says. him through a megaphone: “The devil—it’s University of Cambridge, has found that talented the devil!” One protester held a sign that read mathematicians are at least twice as likely as Shot of fear “TERRORIST” with a photo of Offit’s face. Just the general population to be autistic, and that A link between autism and the routine MMR before Offit reached the door, a man dressed in mathematics students at Cambridge are more vaccine first surfaced in 1998, when British a prison uniform grabbed Offit’s jacket. “It was likely than other students to have a sibling or gastroenterologist reported harrowing,” Offit recalls. parent with autism. Baron-Cohen, whose results that of 12 autistic children he had observed, 8 Moms against Mercury and other such groups are in press in the journal Human Nature, says his had suddenly regressed into autism within days say that autism is triggered by the routine vaccine observations suggest that a group of genes may of receiving an MMR shot (Lancet 351,637– for , mumps and rubella (MMR), by code for both mathematical ability and autism. 641; 1998). The paper set off a media frenzy, the preservative thimerosal, or a combination Several teams have detected potential and over the next four years, vaccination rates of the two. Dozens of peer-reviewed studies genetic ‘hot spots’ for autism, but the factors in Britain fell from 91% to 85%. Wakefield was and scientific panels have dismissed these that influence the expression of these genes widely criticized for this report, and in 2004, links, but, galvanized by a high-profile claims are complex, leaving much of the disorder a 10 of the paper’s 13 authors retracted their trial, congressional support and a buzzing mystery. conclusions (Lancet 363, 750; 2004). online network, this movement—informally What is known is that autism diagnoses Every large study that has looked at the dubbed ‘the Mercurys’—has only become more across the world have skyrocketed in the past incidence of autism and rates of vaccination organized. The movement’s rising visibility, few decades. Before 1990, the reported autism has concluded that there is no link between the public health experts warn, might spur lawsuits prevalence in America was 4.7 out of every 10,000 two. In 2002, a study analyzing data on more against vaccine manufacturers and ultimately children; it’s now 60 per 10,000. The Mercurys than 500,000 Danish children born between lower national immunization rates. call this an ‘epidemic’ Offit has been a prime target of these groups that correlates exactly for years. In 1996, after he published his first book with the rise in the on vaccines, he received a few negative emails and number of vaccinations letters. But by 1999, when the controversy over that children receive, thimerosal reached its peak, the harassment had from 10 in 1983 to 36 “entered a darker place,” he says. in 2007. He has since received hundreds of malicious Epidemiologists and threatening emails, letters and phone say the rise in autism calls accusing him of poisoning children and diagnoses is instead a “selling out” to pharmaceutical companies. result of a broadened One phone caller listed the names of Offit’s two definition of autism young children and the name of their school. spectrum disorders. One email contained a death threat—“I will Children with autism hang you by your neck until you’re dead”— are sometimes that Offit reported to federal investigators. diagnosed as mentally Target practice: Vaccine expert Paul Offit has received hundreds of And he is just one of the many scientists who retarded, eccentric threatening emails, letters and phone calls.

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1991 and 1998 found that those given the MMR parent groups, who have repeatedly vaccine were no more likely to develop autism accused CDC scientists of corruption. than those who didn’t get the vaccine (N. Engl. “The CDC has a revolving door J. Med. 347, 1477–1482; 2002). Another study in with the pharmaceutical companies, the UK of nearly 6,000 children found the same and they’re the ones setting the vaccine rates of vaccination among autistic children as schedule,” says Ginger Taylor, who among non-autistic ones (Lancet 364, 963–969; has an autistic son and maintains the 2004). Adventures in Autism blog, which she “There have been a variety of designs done says receives about 500 visitors a day. by different investigators worldwide, with The Mercurys, too, have been accused different samples and different methods,” says of financial corruption. epidemiologist Eric Fombonne, a researcher on On websites and newspaper the UK study, “and all absolutely failed to show advertisements, they tout the benefits any association with vaccines.” of—and profit from—untested In 2004, following four years of interviews with approaches, including hyperbaric oxygen experts and review of more than 200 scientific tanks, chelation creams and testosterone studies, the US Institute of Medicine dismissed inhibitors, that supposedly remove any link between autism and vaccines. mercury and other environmental The Mercurys dismiss these and other reports toxins from the body. “An ever-growing and argue that the only way to settle the dispute number of practitioners are getting is to compare the rates of autism between aboard this gravy train because they vaccinated and unvaccinated children. realize it’s making a lot of money,” To that end, a nonprofit group called Leitch says. Generation Rescue commissioned a $200,000 Scientists note that some chelating telephone survey of 17,000 children in California treatments carry the risk of liver failure and Oregon. Results of the survey, released on and allergic reactions. In July, a UK 26 June, suggested that boys who have been family whose five-year-old autistic son immunized—with any vaccine—have a 155% died of cardiac arrest after a chelation greater chance of developing a neurological treatment announced that they would

disorder such as autism than boys who are sue the Pittsburgh-based doctor who Images PAVANI/AFP/Getty PASCAL unvaccinated. had prescribed the treatment. But many : Parents of autistic children say scientists parents who use the treatments say they are hiding evidence that vaccines cause autism. Mistrust and manipulation work wonders. “They are bringing our Both the results and the methods of the poll children back to us,” Taylor says. “Some The trial concluded on 26 June but are controversial, however. The pollers asked children are coming all the way back.” deliberations by the three ‘special masters’ who parents if their children had been vaccinated, oversaw the case are expected to take at least six unvaccinated or partially vaccinated, without Science on trial months. defining what the term ‘partially vaccinated’ Starting on 11 June, a vaccine court at the US If the special masters find in the family’s favor, meant, or noting what specifically the children Court of Federal Claims in Washington DC scientists warn, the family is likely to receive had been immunized against or when. heard the case of 12-year-old Michelle Cedillo, $250,000 and paid medical expenses for the Generation Rescue did not release analyses of who has autism and suffers from arthritis, rest of Michelle’s life. If most of the 4,800 cases statistical significance, and because the poll did grand mal seizures and severe gastrointestinal turn out similarly, the National Vaccine Injury not report how many people refused to take the problems. The Cedillos are one of 4,800 Compensation Program could go bankrupt. survey, the results may have selection bias. A families who are seeking compensation from But researchers also worry about what Generation Rescue spokesperson did not return the government for what they say are vaccine- will happen if the Cedillos don’t win. calls made for this article. related injuries. Anesthesiologist Jim Laidler, who a few years Still, on 22 June, US Congressional The Cedillos’ case hinges on a theory ago was “neck-deep” in alternative autism representatives reintroduced a bill submitted proposed by heavy metal toxicologist H. Vasken therapy for his two autistic children, has since last year that calls for the National Institutes Aposhian, who testified on the family’s behalf. turned to mainstream scientists’ side. In 2005, of Health to conduct a comparative study of Aposhian says the thimerosal in six vaccines after publishing a statistical paper in Pediatrics vaccinated and unvaccinated populations. Michelle received before she was seven months that rebuffed the idea of an autism ‘epidemic’, But epidemiologists say such a study isn’t old triggered an “immune dysregulation” that he received about 30 emails and a dozen hostile feasible, because autism prevalence rates are nine months later allowed the weakened phone calls from the Mercurys, one of which he relatively low and rates of unvaccinated children measles virus in her MMR vaccination to reported to the police. are lower still. take root in her gut. Once there, he says, the “This stuff is frighteningly violent,” Laidler “This is just political manipulation,” adds replicating virus caused neurological damages says. “With the Omnibus trial looking like [the Fombonne, who says he has also received and inflammation in her bowels. “These are Cedillos] are going to go down in flames, I would threatening emails and phone calls. “There’s hypotheses,” Aposhian says. “We are now in the be appalled, but not surprised, to hear that some no reason not to trust the data that we already stages of trying to find a possible mechanism act of violence was carried out.” have.” by which autism is caused by the injection of Virginia Hughes is a freelance writer based in Trust is certainly in short supply among these vaccines.” New York.

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