NEWS

p983 Dig deep: p986 Root of all bias: p988 Climate control: Cell phones are Should scientists Paul Epstein tracks set to help find be barred from the effect of arsenic-free water financial conflicts warmer weather in Bangladesh. of interest? on diseases. AIDS meeting spotlights pills to prevent infection

Gels, creams and pills that can prevent HIV think about it, what is more female-controlled infection are the most promising new tools in the than taking a pill in the morning that can 38.6 million Number fight against HIV/AIDS: that was the recurring protect you from getting infected?” infected with HIV worldwide th theme at the 16 internationalinternational AIDSAIDS conferenceconference 4.1 million Number of new in Toronto in August. Trials and tribulations infections in 2005 Faced with growing numbers of HIV The concept of using antiretroviral drugs is infections and the dim prospects of a vaccine to not new. Drugs such as AZT and nevirapine 1.65 million Number of prevent them, researchers are pinning their hopes have been used in HIV-positive pregnant individuals on antiretroviral on circumcision, microbicides and antiretroviral women to prevent transmission of the virus therapy drugs taken to thwart HIV infection. to their children. Members of some high-risk 8,000 Number of deaths Trials of 16 microbicides, championed by the groups, such as men who have sex with men, eacheach dayday fromfrom AIDS-relatedAIDS-related Bill & Melinda Gates Foundation and others, are already thought to take AIDS drugs as illnessesillnesses are under way in Africa and India. Five of those prevention. are in advanced trials and results are expected If rigorous trials back the use of these pills 9% Proportion of adults at next year. One large trial last year showed that for preventing infections, several questions riskrisk withwith accessaccess toto condomscondoms circumcision can reduce HIV infections by up follow: who would pay to provide the pills, to 60% (Nat. Med. 11, 1261; 2005). and to whom? What about the potential for 33% Proportion of US But antiretroviral drugs are only just beginning misuse and for resistance to the drug? Is it fundsfunds forfor preventionprevention setset to get attention as a means of prevention. safe to give these potentially toxic medicines asideaside forfor abstinenceabstinence In his keynote speech, Bill Gates said his to otherwise healthy individuals? foundation would dedicate funds for drugs that A few concerns arose even before the trials prevent HIV infection. “Oral prevention has began. Activists asked whether the drug would be Against abstinence not gone as fast as it should,” he said. “We blame available to participants after the trial ended and Solutions to the many other ethical concerns are ourselves for not pushing that more.” whether those who become infected during the starting to emerge. Tenofovir is long-lasting and An early trial, funded by the foundation and trial would be cared for long term. The intense safe. Other antiretroviral drugs, such as 3TC, led by the nonprofit Family Health International, media scrutiny that followed shut down studies have been available longer and are known to be has shown that the antiretroviral drug tenofovir in Cambodia and Cameroon. safe even after long-term use. (Viread) is safe when given to healthy people. Trials since then have taken these concerns To combat the potential problems with Because too few people became infected during into account, says Peterson. For instance, she resistance, ideally some companies would reserve the trial, however, it is not yet clear whether the says, researchers negotiated to provide treatment specific drugs for prevention, says Lange. Despite drug can protect against HIV, says Leigh Peterson, for at least 15 years to trial participants in Ghana all the hurdles that remain, he says, “I still think lead investigator of the trial. who became infected. it’s far easier in the end to do this than to put 30 Other trials of the approach are million people on therapy.” under way in Thailand, Botswana, Peru Researchers at the meeting also and the US, testing either tenofovir or discussed the use of cervical barriers, Truvada, a combination of tenofovir and such as diaphragms, and suppressing emtricitabine. Results from the Thai trial, herpesvirus infections, which increase expected next year, should clarify whether HIV risk by up to three times. the approach works. For the first time, world leaders also These studies are testing the method in loudly criticized the US government’s sex workers, men who have sex with men emphasis on abstinence. President and drug users—high-risk groups for Bush’s $15 billion AIDS program whom the drugs are likely to be the most earmarks 33% of its prevention funds effective. Oral drugs would also allow for abstinence-based programs. women to protect themselves without the “On balance, this program has knowledge or cooperation of their partners, done a lot more good than harm,” said notes Joep Lange, an AIDS specialist at the former President Bill Clinton. But “an

University of Amsterdam. Presse France Uzon/Agence Jorge abstinence-only program is going to “There’s an enormous need for female- Safety first: New tools for prevention and the US policy on fail.” controlled methods,” Lange says. “If you abstinence were hot topics at the AIDS meeting in Toronto. Apoorva Mandavilli, Toronto

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Mysterious ‘Morgellons disease’ prompts US investigation

She felt as if something piece of Saran Wrap. were crawling on her. “Such patients are a The skin on her arms, challenge to help and legs and face erupted to treat,” he says. “They into lesions, harboring want to be believed what looked like small above all and tend to eggs and creatures with be socially isolated.” flagella; and stiff, white, Scheinfeld says the cotton-like threads Internet has helped those emerged from her thighs. with parasitic delusions She tried spraying herself to band together and

down with vinegar and LLC Media, Medical Interactive reinforce each others’ slathering on scabies Disease or delusion? Skeptics say lesions in Morgellons disease (left) are similar to those caused beliefs. cream bought off the by patients’ neurotic scratching and picking (right). To the sufferers, Internet. nothing could be more But the worst part, says Susan—she prefers not Rutz is being diplomatic. real. In her most recent email, Susan said light to use her last name—was that no one believed Most dermatologists deny the disease yellow worms were crawling out of her face and her. exists, saying the people who claim to suffer black crud was oozing from her pores. “I’m in Then a few months ago she found an online from it have either common skin illnesses or tears, I’m afraid, I’m screaming I am so scared community, all of whom suffered similar psychological disorders such as delusional and distraught,” she said. ghoulish symptoms, and had christened their parasitosis, in which people become irrationally At least one scientist—albeit not an expert condition ‘Morgellons disease.’ The virtual convinced that they harbor parasites. In such in the field—is taking it seriously. Morgellons Morgellons Research Foundation has around disorders, people often have lesions, but those patients have masses of dark fibers visible at 5,000 registrants. are caused by the patients’ own scratching and ×60 magnification under the unbroken skin, “I felt so relieved,” she says. “I found all these picking. while unaffected individuals do not, says Randy people talking about the same thing I was.” “There really is no scientific basis at this Wymore, assistant professor of pharmacology After months of futile campaigns—and claims point to believe that this is real,” says Stephen at Oklahoma State University. “That took away of a cover-up by the government—she and her Stone, president of the American Academy of any possibility that this was not a real thing,” fellow sufferers can claim a small victory: in Dermatology. Many patients with symptoms Wymore says. June, the US Centers for Disease Control and similar to Morgellons respond well to Wymore usually works on potassium Prevention (CDC) began investigating the antipsychotics, Stone says. But “admittedly, there channels but is now planning to investigate phenomenon. are some that did not. I guess you have to keep the nature of the fibers, which he says are The agency plans to first define Morgellons an open mind to the possibility that something quite unlike those from textiles. “This is quite with a set of criteria that distinguishes it from is going on.” a mystery,” he says. “It is both intellectually other illnesses. “It is likely that for many of Noah Scheinfeld, assistant clinical professor intriguing and frightening. We cannot be so these people, they can be helped through of dermatology at Columbia University, says intellectually arrogant as to believe there is another case definition,” says Dan Rutz, a CDC patients sometimes come in with pieces of their nothing new under the sun.” spokesman. skin mixed with other materials in a box or a Emma Marris, Washington, DC University shuts down virologist’s work on questionable AIDS drug The University of Cape Town in South Africa from his research duties and closed his the drug’s manufacturer, Stellenbosch- has set up a committee to assess charges of laboratories. A preliminary investigating based Secomet. The agency has referred the professional misconduct against virologist committee concluded that there was prima matter to the Department of Health Law Girish Kotwal. facie evidence for charges of misconduct Enforcement Unit, which is investigating The move follows a Nature Medicine against Kotwal. the issue. “The [council] considers anything article that linked Kotwal with Secomet V, According to Skye Grove, a spokesperson making medicinal claims about HIV/AIDS in an herbal remedy touted as an HIV/AIDS for the university, a formal university a very serious light,” says registrar Mandisa therapy (Nat. Med. 12, 723–724; 2006). Committee of Inquiry, which has disciplinary Hela. Kotwal, who is head of medical virology powers over academic staff, is investigating Officials from Secomet declined to at the university’s Institute of Infectious the charges. The committee is assessing comment. Disease and Molecular Medicine, published whether Kotwal is guilty of violating rules for Kotwal declined to comment on the a report of the compound’s in vitro antiviral the approval of research on human subjects investigation but told Nature Medicine, activity and promoted Secomet V’s antiviral and adequate standards of care for research “Misinformation and twisted information and properties to both local and inter national animals and of the misleading publication of wrongful linkages and over-sensationalization media. research results. cause severe and irreparable damage that will Five days after the article’s publication, In the meantime, South Africa’s Medicines not go unchallenged in a due process.” the university on 3 July suspended Kotwal Control Council is taking action against Natasha Bolognesi, Cape Town

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Drug companies accused of stalling tailored therapies

Therapies tailored for people’s distinct genetic agreed after the researchers threatened to sue. also shown industry that such drugs can earn makeup have for years been touted as the next Companies have also prevented scientists from significant profits, he adds. big thing in drug development. But if those drugs publishing data that stratified drug responses by In the absence of tests that can single out have yet to materialize, it may be because drug genetic factors, he says. people who would most benefit from a drug, companies don’t want them to. But drug makers maintain that they are however, most drugs continue to be prescribed A July report based on dozens of trying to identify genetic factors that affect their indiscriminately. Some biotechnology companies pharmaceutical company documents and filings products’ effectiveness. “Critical generalizations such as Third Wave Technologies in Wisconsin with the Securities and Exchange Commission are unfounded,”,” says Stephen Lederer, senior and Massachusetts-based Genzyme Genetics says companies often abandon drugs that would director of media relations for Pfizer. “When we are trying to develop tests that can be marketed benefit only a genetic subset of people, and even have robust data, this is shared, as appropriate, along with drugs. obstruct research on genes that would predict with regulators and the scientific community.” Research has already shown that customizing drug response. In March 2005 the FDA amended its guidelines drugs to genetic makeup can benefit public “There’s lots of hand waving about how big to have companies voluntarily submit genetic health. For instance, British researchers have companies are going to develop pharmacogenetic data with new drug applications. Under these shown that individuals with type 1 diabetes who drugs,” says Adam Hedgecoe, coauthor of the guidelines, companies can apply to broadly have certain mutations in two genes respond report, published by the UK Pharmacogenetics market a drug despite what the data might poorly to insulin and fare better on sulfonylurea Study Group. suggest. But if a drug is not approved, the FDA drugs (N. Engl. J. Med. 355, 467–477; 2006). “But companies are using pharmacogenomics can deny companies that hold back genetic data Prompted by those results, the UK government to weed out drugs at an early stage,” he says. the chance to reapply and include the data. has begun training a national network of nurses “[They] don’t develop a drug that’s only going Since the guidelines have been introduced, to implement genetic testing for diabetics. to work for 20% of the population.” companies have been more willing to disclose “If policymakers are serious about applying In one example, a leading drug company data linking certain genes to drug response, the science to public health,” Hedgecoe says, “they refused to provide its product to academic says Judes Poirier, director of the McGill Centre need to engage with what is actually happening researchers for a clinical trial assessing genetic for Studies in Aging, who has for years worked rather than what people hope companies are and lifestyle factors that predict response to a closely with industry. The success of the tailored doing.” drug for Alzheimer disease. The company only cancer therapies Herceptin and Gleevec has Gunjan Sinha, Berlin Text messages dig up pure water for Bangladesh’s poor The teenage craze of text messaging will soon it isn’t as though there’s a beautiful bell-shaped enable Bangladeshi villagers to tap into safe curve,” says Andrew Gelman, a statistics expert water supplies. A new program developed at Columbia University who helped develop by Columbia University scientists uses cell the database. The water may be untainted at phones to help villagers digging wells avoid 100 feet in one well, for instance, and at more water contaminated with arsenic. than 300 feet in a neighboring village. About half of Bangladesh’s estimated 7 With Welltracker, villagers can use text million private wells draw groundwater laden messaging—increasingly popular in the with naturally occurring arsenic. That puts country—to find out how deep to dig and the nearly 35 million Bangladeshis at risk of being odds that the water will be safe at that depth. poisoned by arsenic in their drinking water, Beginning in October, people in Indonesia according to the World Health Organization. also plan to use text messaging to rapidly relay “People still don’t know how to find safe information about bird flu. water,” says lead researcher Alexander van “It’s certainly the most straightforward way Geen, a geochemist at Columbia University’s to make the information easily avail able to Lamont-Doherty Earth Observatory. “We anyone,” says Charles Harvey, a hydrologist want to provide information at the village Schoenfeld Amy at the Massachusetts Institute of Technology, Not a drop to drink: Water in Bangladeshi wells is level so people can dig safe wells.” who is not involved with either project. laced with naturally occurring arsenic. The Welltracker database tracks the Installing wells can cost about $1 for every concentrations of arsenic in 300,000 wells in discovered arsenic in the groundwater. foot villagers dig. By helping find safe water at 17 of Bangladesh’s 520 districts. The team Because other drinking water sources are shallower levels, the database will cut the cost last year completed a pilot project and plans scarce, however, villagers continue to install of digging new wells, the researchers say. to incorporate 5 million more wells into the wells despite the threat of skin lesions, cancers, Before the project can be expanded, the system for a nationwide launch in 2007. cardiovascular disease and respiratory World Bank must first release data from a Bangladesh began installing wells in the problems. The water is untainted—or, at study it funded on arsenic concentrations 1970s as an alternative supply of drinking water least, contains less than 50 parts per billion of in 5 million wells across the country. The because surface water in most places teemed arsenic—below a certain depth, but finding researchers hope to obtain that information with bacteria. The move helped cut diarrheal that level is tricky. later this year. diseases in half, but in the 1990s researchers “The level of arsenic varies a lot by location, Alisa Opar, New York

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20-Jul At least 28-Jul The 20-Jul About 18% of 997 US Food 1.5 million US UK government and Drug Administration scientists residents are allows women surveyed say they’ve been asked harmed or killed undergoing to withhold or alter findings, 40% each year because in vitro fear retaliation for voicing safety fertilization to of medication concerns in public and only 47% donate eggs think the agency routinely provides errors, according to a US Institute of for embryonic stem cell research complete and accurate information Medicine report. in exchange for treatment at a to the public, according to a reduced cost. report by the Union of Concerned 20-Jul A scientific paper detailing Scientists. a failed attempt by Panayiotis 31-Jul A bird flu pandemic may Zavos, director of the Cyprus-based be less likely than expected, US 24-Jul The European Union agrees cloning company Reprogen Ltd., to researchers report, based on an to continue funding embryonic create a cloned child is published experiment combining the H5N1 virus stem cell research using existing (Arch. Androl. 52, 243–254; with a common human flu strain. cells despite calls from Germany 2006). and seven other countries to restrict 1-Aug A US Institute of Medicine funds. 20-Jul The proportion of female panel recommends loosening lead and senior authors of papers regulations to allow in six leading US medical journals 31-Jul has increased significantly over prisoners to Singapore the past 35 years, but still lags participate biotechnology behind that of male authors (N. in research company Engl. J. Med. 355, 281–287; (Nat. Med. ES Cell 2006). 12, 3; 2006). International Pte. Ltd. 21-Jul Indian health authorities 1-Aug An claims it has call for the repeal experimental created six of a 145-year- obesity vaccine lines of human old law against allows rats to embryonic stem cells fit for use in homosexuality chow down human clinical trials. because they fear and stay it is deepening the slim, scientists at Scripps 24-Aug24-Aug A singlesingle cellcell takentaken AIDS epidemic in Research Institute report (Proc. from an embryo can generate the country. Natl. Acad. Sci. doi:10.1073/ embryonic stem cells for research pnas.0605376103). purposes while leaving the embryo 21-Jul The Chinese Academy of unharmed, researchers at Advanced Sciences announces a plan for a 1-Aug The so-called ‘Bubble Boy’ Cell Technologies report (Nature massive data-sharing project that disease makes mice particularly 10.1038/nature05142). researchers at its 90 institutes would susceptible to cancer caused by be able to access. gene therapy, explaining why some 1-Aug1-Aug TThehe headhead ofof children who received gene therapy France’s National 22-Jul Singapore’s government developed leukemia, American Cancer Institute, announces plans to shut down its researchers say (Proc. Natl. Acad. David Khayat, eight-year research collaboration Sci. 103, 11730–11735; 2006). abruptly with Johns Hopkins University, and resigns both sides blame each other for 3-Aug A MassachusettsMassachusetts after 15 failing to deliver on goals. judge orders additional months on environmental review the job. An 24-Jul A review of 70 studies on of the proposed anonymous alternative treatments finds little level-4 biodefense letter in March claimed there was proof that commonly used remedies laboratory at Boston corruption at the institute, but an for alleviating menopause symptoms University, but independent investigation in June work (Arch. Intern. Med. 166, 1453– construction of the cleared him of wrongdoing. 1465; 2006). $178 million building is to continue.

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4-Aug Women scientists are less first reported in June by Chinese likely to patent their findings, even researchers (N. Engl. J. Med. 354, 31-Jul The US when their work matches that of 2731–2732; 2006). Food and Drug their male colleagues, according Administration to researchers at Harvard Business 14-Aug SSamplesamples ofof thethe monoclonal announces that School (Science 313, 665–667; antibody TGN1412, which triggered it will consider 2006). organ failure in six men, were not approving the contaminated, the trial researchers controversial 5-Aug CContraryontrary toto prevailingprevailing notions,notions, report (N. Engl. J. Med. doi:10.1056/ ‘morning-after poor nations with the least developed NEJMoa063842; 2006). pill’ for sale without a health systems are the most likely Andrew von Eschenbach to make rapid use of grants from 15-Aug AAdeldel MahmoudMahmoud stepssteps downdown prescription. the Global Fund, Harvard University as would-be leader of the Global HIV The announcement comes researchers say (Lancet 368, 483– Vaccine Enterprise, just four months three days before Andrew von 488; 2006). after the announcement that he would Eschenbach, President Bush’s lead the alliance. nominee as head of the agency, 6-Aug DDavidavid Oakley,Oakley, oneone ofof sixsix appears before the Senate for his victims of the disastrous TGN1412 15-Aug AAnn estimatedestimated 9,1879,187 drugsdrugs confirmation hearings. “Elephant Man” trial, are missing from a US Food and Drug announces that he Administration directory, but 34,257 15-Aug15-Aug PPresidentresident BushBush nominatesnominates has early symptoms of medications no longer on the market surgeon John lymph cancer. are catalogued, reports the inspector Niederhuber for general of the US Department of director of the US 7-Aug Iranian Health and Human Services. National Cancer scientists join the flock of Institute. Unlike researchers who have cloned 17-Aug SSouthouth Korea’sKorea’s disgraceddisgraced his predecessor, farm animals, although their stem cell scientist Woo-Suk Andrew von cloned sheep died minutes after Hwang resumes cloning research Eschenbach, being born. funded by private Niederhuber support, but still is an 7-Aug Ketamine, an lacks government experienced anesthetic, relieves approval to John Niederhuber cancer depression symptoms conduct human researcher. in hours instead of embryonic stem Eschenbach is the President’s weeks, but can also cell research. nominee for director of the Food and cause hallucinations Drug Administration. and euphoria, US 22-Aug AAfterfter a researchers report. successful pilot 17-Aug17-Aug TThehe USUS FoodFood andand phase, experts give the UK Drug Administration and the 9-Aug HHIV-infectedIV-infected Biobank—which aims to Massachusetts Institute of patients in sub-Saharan Africa stick collect medical samples and Technology team up to develop an to antiretroviral treatments better than data from half a million people automated system that would detect their North American counterparts do, over the next four years— unanticipated problems with drugs Canadian researchers report (JAMA permission to roll out its program and medical devices by scouring 296, 679–690; 2006). nationwide by the end of the year federal and private healthcare (Nat. Med. 11, 696; 2005). databases. 9-Aug TThehe BillBill & MelindaMelinda GatesGates Foundation announces a $500 20-Aug HIV disarms T-cells, million donation over five years the body’s main defense against to the Global Fund to Fight AIDS, viruses, by switching off a key Clarification: An article on the cervical cancer protein on the cells, scientists Tuberculosis and Malaria. vaccine published in the July issue (Nat. Med. 12, 721; 2006) attributed the vaccine to scientists report. The finding may help 9-Aug CChinahina admitsadmits thethe country’scountry’s at the US National Cancer Institute. Researchers restore immune function from Georgetown University, the University of first bird flu case was in 2003, two (Nature Med. doi:10.1038/ Queensland, Australia, and the University of nm1482; Nature ddoi:10.1038/oi:10.1038/ years earlier than was originally Rochester were also involved in developing the nature05115). reported. The discrepancy was technology.

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the executive director of the Center. “Look at A few good scientists what JAMA has gone through. I hope that other journals won’t wait to be burned.” DeAngelis, writing in a 7 August editorial in Researchers who have no financial entanglements with companies JAMA, dismissed the idea of a publication ban, are a rare breed. Given that, asks Meredith Wadman, is the push saying that it would simply drive offending authors to other journals. “It cleans our house to police conflicts of interest realistic? by messing others,” she said. But Jacobson and others say that greater transparency is essential as scientists increasingly For the editors of the Journal of the American “We’ll get killed,” JAMA’s editor-in-chief, forge close ties with the industry. Medical Association, this has been a summer of Catherine DeAngelis, told the Associated “The pressure that has been put on journals discontent. Press whenwhen thethe fourthfourth episodeepisode becamebecame public,public, and on federal agencies really boils down to trying In two short months, the prestigious medical speaking of damage to the journal’s reputation. to build back public trust in the institutions of journal has published four corrections detailing She declined to be interviewed for this article. science,” says Sheldon Krimsky, a Tufts University significant financial conflicts of interest that its Despite the bad ink that has plagued JAMA, expert on conflicts of interest in biomedicine. authors had not previously revealed. the journal is just one of many struggling to Essential to rebuilding that trust, Krimsky The most damaging case involved a widely adapt to scientists’ increasing entanglement with argues, is the cultivation of a sizeable cadre of publicized paper that concluded that women who companies. biomedical researchers with no commercial ties. stop taking antidepressants during pregnancy are Other journals are revisiting disclosure Some government agencies, at least, are at an increased risk of relapse. On 11 July, The policies that are for the most part more lenient moving in that direction. Wall Street Journal rreportedeported tthathat 9 ooff 1133 aauthorsuthors than JAMA’s. Government agencies are setting In 2005, following embarrassing press reports on the paper are paid consultants or lecturers for stricter standards. Vigilance by advocacy groups, of its scientists collecting undisclosed six- antidepressant makers—and had, in all, more the press and even Congress is increasing—as are figure consulting payments, the US National than 60 different financial relationships with calls for serious sanctions against offenders. Institutes of Health launched a controversial companies—but did not disclose those ties. “There is more alertness to violations,” policy banning employees from consulting for The other offenses were somewhat more says Arthur Caplan, director of the Center for biomedical companies, and obliging senior obscure, but no less clear-cut. Bioethics at the University of Pennsylvania. scientists to divest their stocks (Nat. Med. 11, The author of a report on big heart trials “There is a whole subcategory of people who 914–915; 2005). didn’t reveal his consulting work for seven related study this now. And they’re watching.” Then, in July, the US Food and Drug drugmakers. Two writers of a review linking a Administration (FDA) announced that it is rheumatoid arthritis treatment to increased Eroding trust modifying its policy on conflicts among external risks of cancer and infections didn’t state that Among those keeping a close eye is the Center advisors who weigh in on drug approvals. they are being paid by Amgen to analyze a for Science in the Public Interest, a Washington- “We are going to aim to be much more competing drug. And all six authors on a paper based advocacy group that in July called for a transparent,” said deputy commissioner Scott linking some migraines to an increased risk of three-year publication ban on journal authors Gottlieb, announcing the changes. stroke, heart attack and death didn’t disclose who flout disclosure guidelines. their relationships with makers of pain or heart “At some point, journals need to put some Judgment calls medications. teeth into their policies,” says Michael Jacobson, Medical journals are also scrambling to revise their policies. The journal Neuropsychopharmacology—a product of the Nature Publishing Group, Nature Medicine’s parent company—was also caught in a wave of bad publicity this summer. The journal’s editor-in-chief, Charles Nemeroff, and his coauthors did not disclose their financial ties in a paper that endorsed vagus nerve stimulation, a controversial, albeit FDA-approved, therapy for treatment-resistant depression. Nemeroff had recused himself from editing the paper, but the $15,000 device for the therapy is made by Houston-based Cyberonics— for which eight of the paper’s nine authors, including Nemeroff, are paid consultants. Nemeroff says the authors’ disclosures were in the original manuscript but were inadvertently dropped from the draft that went to press. “It was an oversight, nothing more,” he says. “We are entirely and absolutely dedicated to full financial disclosure.” He declines to say how much he is paid by Cyberonics.

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As a result of the incident, Nemeroff says he Most famously, a 32-member panel of external is considering adopting a new policy: requiring Summer of Infamy advisers voted by narrow majorities in February authors to provide a list of all their financial May 2006 2005 to recommendthe continued sale of Vioxx relationships with companies in every manuscript Authors of a JAMA report on two and Bextra, two blockbuster painkillers clearly they submit. The journal now leaves it to authors rheumatoid arthritis medications posing associated with increased risks of heart attacks to judge—and disclose—which of their financial increased risk of serious infections and and stroke. Shares of Merck and Pfizer, the drugs’ interests are relevant to the subject of an article. cancer are found to be paid by Amgen makers, shot up in response to the news. to analyze a competing drug. “That’s a judgment call that in this climate could One week later, The New York Times reportedreported be viewed as problematic,” Nemeroff notes. June 2006 that 10 of the 32 advisers had consulted for the The incident wasn’t Nemeroff’s first brush with NIH researcher Trey Sunderland is makers of the two drugs, or for Novartis, which this issue. In 2003, The New York Times reported reported to have collected $612,000 was preparing to market a very similar pill. Had that Nemeroff had lucrative financial ties to in unauthorized fees from Pfizer and these advisers not voted, the committee would two companies whose drugs he had touted in a provided thousands of spinal fluid not have decided in the drugs’ favor. Nature Neuroscience review on mood disorders. samples to the company. These competing interests were not revealed to July 2006 Free pass readers. Nor was the fact that Nemeroff held the Seven authors of a February JAMA study, In April, a study by the activist group Public patent on another treatment—a lithium patch— which concluded that women who stop Citizen—published, ironically, in JAMA— that he applauded in the article. taking antidepressants during pregnancy reported that 28% of about 2,000 FDA advisory But Nemeroff had not violated Nature greatly increase their risk of relapse, panel members between 2001 through 2004 Neuroscience’s policies at the time, which didn’t are found to be paid consultants disclosed conflicts of interest. require financial disclosure from writers of of antidepressant makers. But the FDA declined waivers for only 1% of reviews. That policy was changed as a result. July 2006 those scientists.Although the study didn’t find a The Nature research journals—which include Neuropsychopharmacology touts vagus statistically significant relationship between the Nature Medicine and Nature Neuroscience—do—do nerve stimulation as a therapy for advisers’ commercial ties and the panel outcomes, not impose sanctions on offending authors, and depression, but neglects to mention that the House of Representatives had by June voted require authors to list their competing financial eight of nine authors, including the to bar the FDA from granting waivers. interests only after a paper has been accepted in journal’s editor, are paid consultants to Under pressure, the FDA in July announced the device’s maker. principle. Authors are also given the option to that it is revising the policy that governs waivers, declare that they have “too many” competing July 2006 aiming to codify decisions that have thus far been financial interests to list. Six authors who report in JAMA that made using qualitative judgments. “We’re probably too liberal about this,” some migraines are linked to increased Deputy commissioner Gottlieb said that says Juan Carlos Lopez, chief editor of Nature risk of heart attack and stroke do not in some cases, the rules may actually be eased. disclose their payments from makers of Medicine. “It’s something that we would like to For instance, the agency may allow experts who heart and migraine medications. revisit, to see if there is any scope for change.” oversee the safety of a drug trial to participate At least one journal has decided to impose in a panel judging that drug without getting a serious sanctions. In 2004, Environmental “It’s what I call the conflict of interest cult,” waiver, as is currently required. The agency will Health Perspectives, which is published by the says Thomas Stossel, a Harvard University also make “more transparent” the legalistic, US National Institute of Environmental Health hematologist who publicly defends commercial redacted documents it now posts to explain its Sciences, adopted a three-year publication ban on relationships between doctors and companies. waiver decisions, he said. authors who willfully flout its disclosure policy. “Transparency is a good thing, but the cult has The FDA will preserve the waiver-granting James Burkhart, its editor, says that he hasn’t carried it to an absurd extreme,” Stossel says. “The process because the best and the brightest experts needed to mete out the punishment because purpose is to accommodate a vigilante informant often have ties to companies, he added. ”If we several breaches, for which he has published culture that is out looking to discount you.” do away with the waiver process,” he said, “the clarifications, have been “unintentional.” The Stossel and others argue that walling off truth is that we are playing it safe rather than aim of the ban, he adds “is not really to punish researchers from the industry is not only playing it smart.” but to deter.” unrealistic but bad for medicine. Playing it ‘safe’ is, in any case, becoming “New drugs and devices are generally developed increasingly difficult. Presumed guilty by companies, often with significant input from “The search for the untainted investigator Is divorcing researchers from commercial academic physicians and scientists. This sort is starting to become like Diogenes’ quest to interests realistic? Or even necessary? of partnership is vital for medical progress,” find an honest man,” says Caplan, invoking the “A lot of people these days have competing says David Shaywitz, an endocrinologist at Cynic philosopher who is said to have spent his financial interests. That is just a fact that Massachusetts General Hospital. days wandering around ancient Greece with a surrounds modern biology,” says Lopez. The FDA has used similar arguments to lantern. “It should not disqualify their ability to do support its reliance on external advisers with Given this, Caplan says, perhaps the response to transparent and honest science.” commercial ties, saying that recruiting the best the recent incidents should be more measured. Many others echo those sentiments, arguing experts sometimes requires accepting some “If you take it to an extreme, you start to say that the recent incidents are fomenting a new degree of conflict. The agency routinely grants that no science that comes out of private industry McCarthyism in which researchers are wrongly itsadvisers conflict-of-interest waivers, allowing is good, because it’s commercial,” he says, “and presumed to be ethically tainted, and their them to vote on drug approvals even when a that can’t be the right conclusion.” work suspect, simply because of their financial company they are working for, or own stock in, Meredith Wadman writes for Nature associations with companies. has a stake in the decision. Medicine from Washington, DC

NATURE MEDICINE VOLUME 12 | NUMBER 9 | SEPTEMBER 2006 987 PROFILE Paul Epstein

Long before climate change was a hot-button topic, Paul Cambridge, Massachusetts, Epstein became intrigued with the idea of Epstein was arguing that warmer temperatures can widen practicing medicine in Mozambique, at the time a newly independent the spread of infectious diseases, disrupt ecosystems and country that was attracting doctors and teachers from all over the world. topple economies. In 1978, he moved there with his wife, who is a nurse, and their children, then three and seven years old. The couple helped set up clinics in Beira, Mozambique’s second largest city, to treat malaria, cholera, tuberculosis He’s not a climatologist, an ecologist or an epidemiologist. But Paul Epstein and other diseases as part of the American Friends Service Committee, a can explain exactly how burning fossil fuels in your backyard can trigger Quaker-run service organization. an infectious disease outbreak thousands of miles away. In the two years the family spent there, some of them fell ill with malaria. Epstein, a physician trained in tropical diseases, has made it his life’s goal The experience might have sent others running back to the States, but to study the acute consequences of climate change on public health. Epstein was nonchalant. “It was treatable, so we’re fine,” he says. “Overall I The warming climate—due primarily to heat-trapping gases from the think [living in Mozambique] was a fabulous, positive experience.” combustion of fossil fuels—can increase weather swings, causing heat The Portuguese Epstein learned then still serves him well, helping him waves, floods, droughts and hurricanes which Epstein says we’re already treat the large number of Portuguese-speaking patients in Cambridge, to seeing. And these weather extremes and warmer temperatures, he says, which the family returned in 1980. enable pests such as malaria-carrying mosquitoes to expand their range. In the late 1980s he established HIV services and a travel clinic Curbing global warming is the key to controlling the 30 infectious at the hospital. “That was a pivotal time, digesting what I had done in diseases that have emerged in the past 30 years, Epstein says. “The way we Mozambique, thinking about the environment and ecological systems and develop energy is not sustainable and it’s having multiple impacts on our how they were related to human health,” he says. health, on our ecological systems and ultimately on economic stability.” As he began studying the relationships between these disparate elements, As associate director of Harvard University’s Center for Health and the his focus shifted from the clinic toward more interdisciplinary projects. At Global Environment, Epstein has brought together insurers, national and the 1992 Earth Summit, a United Nations–sponsored meeting in Rio de global agencies, and scientists from multiple disciplines not usually known Janeiro, Epstein suggested that warmer ocean temperatures enhanced large for their cooperation to study the issue. blooms of plankton harboring cholera bacteria, triggering the 1991 cholera The impact on economies in particular caught the attention of insurers, outbreak in Peru (Biosystems 31, 209–221; 1993). The disease eventually prompting Swiss Re, a global reinsurance company, to collaborate with the spread to Mexico, killing 4,000 people and damaging the economies of United Nations Development Program and academic scholars in examining several countries. Though thousands of journalists covered the summit, the effects of climate change. The report, which Epstein coauthored, went only the Wall Street Journal gavegave iitt aanyny aattention.ttention. out to Swiss Re’s clients and members of the US Congress and is used in “That was a time when health and global environmental concerns really classes at Columbia and Harvard Universities. were not recognized at all,” Epstein says. “Paul has enormous drive and energy to work on these issues,” says Eric Despite strident skepticism about his theories, he continued his work, Chivian, the Harvard center’s founding director and winner of the 1985 linking climate change to allergies, asthma and a range of diseases, including Nobel Peace Prize for his work on nuclear disarmament. “He’s able to make those caused by hantavirus and the West Nile virus. connections that many people are not able to make.” Most recently, Epstein reported in June that if global carbon dioxide levels Convincing skeptics that climate can feed disease outbreaks proved increase as predicted, ragweed pollen production will spike by as much as challenging from the start. But the idea gained support, in part owing 55%, triggering allergies (Environ. Health Perspect. 114, 865–869; 2006). to Epstein’s skill at weaving dry information into a “The direct impact of carbon dioxide on plants is having this unexpected compelling story. side effect for public health,” he says. “When Paul speaks, people listen,” says But critics say Epstein tends to glaze over complex relationships. Virginia Burkett, a wetlands researcher at the “Yes, there’s climate change; yes, it could have an impact on these US Geological Survey. diseases because they’re temperature sensitive,” says Duane Gubler, who Despite his lofty goals, Epstein still makes was director of the US Centers for Disease Control and Prevention’s time to see patients and flies to meetings all division of vector-borne diseases until 2004. “But it is an oversimplification over the globe—England, Iceland, Germany and to simply say that increased temperature is going to equate to increased Mozambique this summer alone. disease incidence.” At 62, the packed schedule can be tiring, Gubler, who is now director of the University of Hawaii’s Asia-Pacific Epstein says, but he has no intention of Institute of Tropical Medicine and Infectious Diseases, disagrees with slowing down. He still rides his bicycle to Epstein so strongly that he says he hasn’t picked up Scientific American work—doing so even during the August heat since the magazine in 2000 ran an article written by Epstein. wave—and has a reputation for trouncing The skepticism doesn’t faze Epstein. younger colleagues at basketball, a game “There’s always been criticism of anyone who associates anything he played growing up in New York with climate,” he says. The threat to human health and City’s Greenwich Village. “The way we develop energy is not ecosystems is “sad and scary,” and it can be difficult Even then, Epstein knew he to talk about, he adds. “I do believe that systems have wanted to be a doctor, seeing it as sustainable and it’s having multiple resilience and they can recover, but we’ve got to back an opportunity to save people and impacts on our health.” off.” to travel. As a young doctor in Alisa Opar, Cambridge, Massachusetts

988 VOLUME 12 | NUMBER 9 | SEPTEMBER 2006 NATURE MEDICINE