Differences on display on US informed-consent rules

Posted on 28 Aug 2013 by Meredith Wadman

Was it enough for doctors to tell the parents of extremely premature infants that there was “no additional risk” to their babies if they enrolled them in a randomized trial? One treatment group, in which the preemies were maintained with higher blood oxygen, risked eye damage. The other kept the babies at lower oxygen levels, risking brain damage and perhaps death. Both were within the range of care that the babies would have received anyway.

That’s one of the loaded questions that senior US health officials grappled with today at an unusual public meeting convened by the National Institutes of Health (NIH) and the Office for Human Research Protections (OHRP), which polices the ethics of NIH-funded clinical trials.

The meeting was called after OHRP set off a firestorm this spring when it told investigators from the multi-site, NIH-funded SUPPORT trial that its consent forms failed to describe “the reasonably foreseeable risks of blindness, neurological damage and death” to the 1,316 infants that participated. (SUPPORT stands for ‘surfactant, positive pressure, and oxygenation randomized trial’, and the paper that resulted from the trial is here.)

At today’s meeting, officials heard from a parade of highly educated speakers, but perhaps the most moving testimony came from the parents of two infant participants in the study.

“They should have conveyed to me the effect of my son’s oxygen level being too high or too low,” said Sharissa Cook, an Alabama mother whose son was born weighing 765 grams (1 pound and 11 ounces). “Had I known the full extent of this study I would not have given my consent.”

Shawn Pratt, a West Virginia man, brought his pig-tailed six-year-old daughter, Dagen, to the meeting. She was born 15 weeks early and had early surgery to correct eye damage, which is a common side effect of high levels of oxygen therapy. She also has cerebral palsy, which can result when premature infants get too little oxygen.

“Why was our child a subject in a medical experiment without our knowledge or permission?” Pratt asked. “We want to understand why the intent of the study was not originally provided to us, as it was envisioned by its designers.”

After the OHRP criticized the study’s consent forms in March, a string of reaction followed from the highest research echelons. They included this commentary in the New England Journal of Medicine by NIH director Francis Collins and his policy deputy, Kathy Hudson. Most of the responses defended the trial and the forms, arguing that the babies were put at no additional risk. But a vocal minority of physicians and bioethicists and the advocacy group Public Citizen have loudly disagreed. So did this Nature editorial, published last week.

Today’s meeting was an effort, in part, to keep the two sides talking — and listening to one another — as the OHRP sets about clarifying the rules for informed consent when treatments that are already in use are being studied. (And studied they will be, in increasing numbers, because the health care reform law of 2010 — otherwise known as Obamacare — has mandated such work.)

The unusual format of the meeting had speakers testifying before three senior officials — Jerry Menikoff, the OHRP director, the NIH’s Hudson, and Robert Temple, who directs the US Food and Drug Administration Center for Drug Evaluation and Research.

It was clear that views remain polarized.

“Randomization to the extremes of a usual care range has very real risks that need to be understood … and disclosed to patients,” argued Robert Danner, a critical care physician at the NIH Clinical Center. (Danner was speaking for himself, and not for the agency.)

“Making the research sound riskier than it really is is problematic,” said David Magnus, a bioethicist at Stanford University in California who spearheaded this letter to the New England Journal of Medicine, criticizing the OHRP for overreaching.

The OHRP’s Menikoff, for his part, said that the two sides are closer than the volume of the recent controversy might indicate. Rather than taking issue with the trial as a whole, he said, “What the Department [of Health and Human Services] was concerned about was the risks, and that those risks were not disclosed.” A couple of sentences in the SUPPORT consent form laying them out plainly would have done the trick, he said.

But Edward Campion, a senior deputy editor of the New England Journal of Medicine, noted that the SUPPORT study consent form was already long, at seven single-spaced pages. “Whether an extra paragraph would have created one more iota of patient understanding is problematic,” he said. “The need for better education and transparency is not accomplished by the consent form.”

A spokeswoman said that the Department of Health and Human Services “will thoughtfully review” the comments it has collected on a public docket that remains open until 9 September. It has no set timetable set for releasing the updated guidance.

Senate bill would boost NIH budget to $31 billion in 2014

Posted on 09 Jul 2013 by Meredith Wadman

Supporters of the US National Institutes of Health (NIH) just got what passes for good news in Washington DC’s current climate of fiscal austerity: the US Senate subcommittee that funds the biomedical agency voted today to boost its budget by nearly US$2 billion, to $31 billion in 2014.

The proposed budget, part of a broader spending bill , would increase top-line NIH spending from the current level of $29.15 billion to $30.955 billion, just shy of the $31.1 billion that President Barack Obama requested in April. The increase would include $84 million new dollars for Alzheimer’s disease research at NIH’s National Institute on Aging and $40 million for the much-watched Brain Research through Advancing Innovative Neurotechnologies Initiative announced by the White House in April.

The Senate panel would also quintuple, to $50 million, funding for the Cures Acceleration Network, an effort by NIH’s new translational medicine centre to speed bench discoveries to the bedside. And the bill would extend to other agencies in the Department of Health and Human Services a requirement that is now operative only at NIH: that researchers deposit their taxpayer-funded manuscripts in a publicly accessible database.

The proposal also includes $10 million for the Centers for Disease Control and Prevention to reinstitute research on the causes and prevention of gun violence. And, departing from the Obama budget request, it includes $276 million — $51 million more than Obama sought – for the Institutional Development Awards programme, which builds research infrastructure in states with historically low levels of NIH funding.

“This is good news for NIH,” says Jennifer Zeitzer, the director of legislative affairs at the Federation of American Societies for Experimental Biology. “It’s absolutely a move in the right direction with regard to our investment in research.”

The Senate subcommittee’s plans are far from a done deal. But the bill, which the Labor, Health and Human Services and Education and Related Agencies Subcommittee passed by voice vote, represents a defiant starting point for Senate negotiations with a far more frugal House of Representatives. To approve a new NIH budget — as opposed to continuing to operate at current funding levels because the two sides can’t resolve their differences — the Republican-controlled House and Democrat-dominated Senate must agree on a common figure for the biomedical agency. The Senate subcommittee, working from a total funding pot of $164 billion for all the agencies covered by its bill, has more room for largesse towards NIH than does its House counterpart, which is starting with a pot of $121.8 billion, or nearly 26% less.

The Senate bill is expected to be passed by the full Senate Appropriations Committee on Thursday.

Senator Barbara Mikulski, the Maryland Democrat who chairs the full committee, made it clear at a press event yesterday at Johns Hopkins Hospital in Baltimore, that she plans to go to the mat for NIH, which under recent sequester cuts lost $1.55 billion of its original 2013 budget of $30.8 billion. Health and Human Services Secretary Kathleen Sebelius’s transfer of $173 million in NIH 2013 funds to other agencies in the department added to the damage.

“We want to say ‘no’ to the slash and crash of reckless cuts to American biomedical research,” she declared against a backdrop of white-coated medical researchers who had gathered to emphasize the impact of sequestration on NIH-funded scientists.

Whether the Senate bill will ever actually be juxtaposed with a House counterpart remains to be seen. “Our action today stands in stark contrast to the House of Representatives,” Senator Tom Harkin, the Iowa Democrat who chairs the Senate subcommittee said. “The House began marking up appropriations bills in May, but so far there are no signs that it plans to consider the Labor-HHS bill.”

The Senate bill will become available after the full committee approves it on Thursday.

NIH retires most research chimpanzees

Posted on 26 Jun 2013 by Meredith Wadman

{credit}Flickr/William Warby{/credit}

The US National Institutes of Health (NIH) announced today that it will retire to sanctuary nearly all of its research chimpanzees — about 310 animals — leaving a rump colony of up to 50 animals available to researchers who can clear high ethical and regulatory hurdles for using them.

The announcement marks the end of a protracted process, kicked off by a landmark Institute of Medicine report, during which NIH-funded chimpanzee research has come under increasing scrutiny. Separately, the US Fish and Wildlife Service last week said it would declare captive chimps endangered, which also would make the animals tougher to access for biomedical research. The United States is the only major country that still funds invasive chimpanzee research.

Francis Collins, the NIH director, called today’s decision a “real watershed”. “I am confident that greatly reducing their use in biomedical research is scientifically sound and the right thing to do,” he said. The decision is outlined in greater detail here.

The NIH said that it would accept all of the recommendations made by an agency working group in January for disposition of the 310 chimpanzees that it now plans to retire, with one exception: in defining appropriate housing going forward, the working group had recommended 1,000 square feet (93 square metres) of space per animal.

“We did not feel there was adequate scientific evidence” to support that requirement, Collins said. He added that the NIH would consult experts and do further review before determining the space allotment that it will require per animal. Under current rules, lab animals can be confined in as little as 25 square feet (2.3 square metres) of space.

The NIH will not breed any of the 50 remaining research animals and will reassess the need for that rump colony in five years, Collins said.

The physical placement of the retiring animals, and which ones to use in the residual research colony, remains to be worked out by the agency over the coming months and years. Chimp Haven in Louisiana, the only existing federal sanctuary, is near capacity, although it is undertaking a private fundraising campaign to allow expansion.

The problem of supporting the retired animals in the future is compounded by a US$30-million cap on their support by the NIH that was written into law in the Chimp Act of 2000. That spending has now reached $29.2 million, says Kathy Hudson, NIH deputy director for science, outreach and policy. She says that the agency is working with Congress to amend the act to allow for future funding, and anticipates needing a new $3 million in 2014.

Collins said that six of nine existing invasive experiments supported by the agency will be ended. He would not specify which ones, ahead of notifying the scientists involved. Directors of the NIH-supported chimpanzee research centres were not immediately available for comment.

Animal-rights groups celebrated most aspects of the announcement. The Humane Society of the United States called it “monumental”. “Nearly all current NIH-funded invasive research will be phased out…and the barrier to new invasive research will be very high,” says John Pippin, director of medical affairs for the animal advocacy group Physicians Committee for Responsible Medicine in Washington DC.

However, chimp research opponents decried the NIH’s decision not to immediately adopt the requirement of 1,000 square feet of space per animal. Stacy Lopresti-Goodman, a psychologist at Marymount University in Arlington, Virginia, works with chimpanzees at the Save the Chimps sanctuary in Florida. She says that groups of 12–25 chimpanzees live there, with an island of 3–5 acres for each group. She says that, even if the NIH abides by the new recommendation, the 50 chimpanzees in the NIH’s scaled-down research colony would be confined to just over 1 acre of space. “It is frankly outrageous that the NIH suggests the conditions for chimpanzees locked in laboratories are in any way comparable to what they are provided in sanctuaries,” she says.

Lopresti-Goodman was responding to a comment by James Anderson, NIH deputy director for program coordination, planning and strategic initiatives, who described the environments in the research centres and sanctuaries as “not tremendously different”.

US regulator plans to declare research chimps endangered

Posted on 11 Jun 2013 by Meredith Wadman

{credit}Flickr: Valentina Storti{/credit}

The US Fish and Wildlife Service (FWS) is planning to categorize all US chimpanzees as an endangered species, a change which, if enacted, may spell the end of invasive chimpanzee research.

This soon-to-be-published proposed FWS rule, which will be open for 60 days of public comment before being finalized, would bring captive chimps — whether in zoos, private homes or research labs — under the protection of the Endangered Species Act, as wild chimps already are.

If the FWS decides to list the captive animals as endangered, then using them for invasive research would require a special permit. To win one, researchers would have to show that any proposed study would promote the conservation of the species.

Jane Goodall, the famous primatologist, called the move “an important step toward saving our closest living relatives from extinction”. She spoke on behalf of a coalition of animal welfare groups, including the Humane Society of the United States, that had petitioned the agency to declare captive chimpanzees endangered.

The coalition noted that populations of wild chimpanzees have fallen more than 65% in the last 30 years, and attributed some of the loss to poaching driven in part by US research. The United States is the only major country that conducts invasive chimpanzee research.

The proposed rule comes as scientists are also awaiting a decision by the National Institutes of Health (NIH) on the future disposition of roughly 360 chimpanzees owned by the agency and now housed at facilities in Texas and New Mexico. In January, an NIH working group advised the agency to retire to sanctuary all but 50 of the animals. The working group was responding to a report from the US Institute of Medicine late in 2011, which declared most research using chimpanzees scientifically unnecessary.

The Federation of American Societies for Experimental Biology (FASEB), which represents many research scientists, said in a statement today that it is “disappointed” in the FWS decision. The endangered designation, it said, “would make biomedical research using chimpanzees difficult and potentially delayed”.

The FASEB added: “Chimpanzees are an important model for both ongoing and future research in certain circumstances. [We] believe the status change will negatively affect the health of both humans and great apes.”

US Institute of Medicine lays out gun-research agenda

Posted on 05 Jun 2013 by Meredith Wadman

When he responded in January to the massacre of 20 schoolchildren and six educators in Newtown, Connecticut, US President Barack Obama issued 23 orders aiming to address the US epidemic of gun violence — including one directing the US Centers for Disease Control and Prevention (CDC) to re-start gun research, which has languished since 1996.

The CDC, in turn, asked the Institute of Medicine (IOM), a branch of the National Academies, to recommend a gun-research agenda. Today, the IOM delivered its recommendations.

The committee that wrote the 69-page report — chaired by Alan Leshner, the chief executive of the American Association for the Advancement of Science — was asked to examine five areas: the characteristics of firearm violence; risk factors and preventive factors; interventions and strategies; gun-safety technology; and the influence of video games and other media.

The panel generated a long list of questions that it said could be pursued. They include whether point-of-purchase background checks actually deter people who are forbidden from owning firearms from getting hold of them, and how effective current policies and laws are at preventing gun sales to people with specific psychiatric diagnoses.

The report suggests a study to determine whether specific safety technologies, such as iris scans and gun-activating magnetic-stripe badges, actually reduce gun injuries and fatalities — and, if they are effective, why they work. And it calls for a look at whether there is a relationship between long-term exposure to media violence and subsequent firearm-related violence. Existing studies on media and video games veer to the short term, it notes, and few of them are specific to gun violence.

The breadth and depth of the unanswered questions point glaringly to how little is known on a huge range of issues, as Nature recently noted in this profile of firearms researcher Garen Wintemute. But funding for studies on even a fraction of the questions the IOM proposes is likely to be limited in a very tight government budget environment.

Obama asked Congress to provide US$10 million in new funds to the CDC next year to begin the research, but it is far from clear that Capitol Hill will oblige. If not, the CDC — which is already confronting a proposed $216-million cut in its congressional budget next year, and an additional 5% across-the-board chop known as sequestration — will have to cut one or more of its other programmes to produce the money.

The IOM committee was not asked to weigh in on funding questions, but it left little doubt where it stands on the value of the research it recommends. “In the absence of this research, policy makers will be left to debate controversial policies without scientifically sound evidence about their potential effects,” they write.

In an e-mailed statement, the CDC said that it “thanks the IOM for developing the report in a timely manner and looks forward to reviewing the report”.

Strapped Texas cancer centre built pricey office suite for president’s wife — UPDATED

Posted on 24 May 2013 by Meredith Wadman

The financially stressed MD Anderson Cancer Center in Houston, Texas, seems to have invested at least US$1.5 million in capital funds in a new ‘corporate’ office suite that will be home to Lynda Chin, the wife of MD Anderson president Ronald DePinho. The revelations come in an article published today in The Cancer Letter.

{credit}Cancer Letter{/credit}

The Letter used the Texas Public Information Act to obtain 680 pages of documents that describe the project as “Dr. Chin Office Renovation”. However, the article argues:

A renovation it was not. The 25,000-square-foot suite, much of it south-facing, is new, located on the sixth floor of the just-constructed South Campus Research Building III.

Chin, who moved to MD Anderson when DePinho became the cancer centre’s president in 2011, is the scientific director of the fledgling Institute for Applied Cancer Science (IACS), a drug-discovery centre, and chair of the cancer centre’s department of genomic medicine. The office was built to house the genomic medicine department and the IACS, which aims to enlist drug companies in promising collaborations. For instance, the IACS in December announced a partnership with drug-maker GlaxoSmithKline, with the goal of producing cancer-fighting antibodies.

Among the itemized expenses reported in The Cancer Letter article are nearly $28,000 for settees, lounge chairs and occasional tables for the IACS, and about $210,000 for translucent walls in the 2,323-square-metre space. The spending on the walls required a variance, or special permission, from the University of Texas system’s executive vice-chancellor for health affairs, Kenneth Shine. (An architect’s rendering of some of the translucent panels is pictured above.)

In a statement to Nature, MD Anderson defended its actions, noting that the IACS has raised $15 million in donations:

The renovations of space for the Institute for Applied Cancer Science and Department of Genomic Medicine — both new entities for MD Anderson — transformed a traditional academic office suite to a work environment and meeting area for a science/business enterprise, a concept new not only to MD Anderson, but most of academic medicine… The existing space was not configured to support this new concept.

The “redesigned” space, it added, would “create an open environment of communication, provide an appropriate meeting space with high-level industry decision makers and support a new suite in computational biology”.

This is not the first time that Chin has landed in the public spotlight since she arrived at the huge, high-profile centre. Last year, there was an outcry after an IACS team headed by Chin was awarded an $18-million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) that bypassed scientific peer review.

The 17 May issue of The Cancer Letter (available only to subscribers) reported that DePinho announced austerity measures — such as suspension of merit raises and slowing of hiring — in an e-mail to MD Anderson employees on 15 May. It read, in part:

For most of Fiscal Year 2013 (FY13), our operating expense has exceeded our operating revenue — meaning that we’ve spent more than we’ve made from providing our patient care services. What we’re facing today is much like what you’d face with your own checkbook if you spent more than you were paid each month for several months.

Updated with new comments from MD Anderson.

Gairdner Foundation honours two of three prizewinners for hepatitis C research

Posted on 02 May 2013 by Meredith Wadman

As they sipped an Ontario sauvignon blanc and munched on Canadian lobster and tuna tartar, guests gathered last night at the Canadian Embassy in Washington, DC for a celebration of two of the prestigious Canada Gairdner Awards. But one key guest was missing.

In March, for the first time since the first awards were made in 1959, a recipient declined the $100,000 prize. That was Michael Houghton, a virologist at the University of Alberta who is a co-discoverer of the hepatitis C virus. Houghton’s co-winners, Harvey Alter of the National Institutes of Health and Daniel Bradley, formerly of the US Centers for Disease Control and Prevention, were honored at the embassy last night, in a sixth-floor reception room with nearly-unparalleled views of the US Capitol.

Introducing them, John Dirks, president and scientific director of the Gairdner Foundation, noted wryly, “Michael chose for the first time in our history to decline this award. I won’t go into that. All I can say is that it did give us a lot of publicity. It’s the old story: All news is good news.”

After declining the award in March, Houghton, who in 2000 shared a Lasker award with Alter for his hepatitis C accomplishments, told the Globe and Mail that he “agonized” after accepting the Lasker, because two of his collaborators at the biotechnology company Chiron were not similarly recognized. Houghton worked closely with Qui-Lim Choo and George Kuo to identify and clone the hepatitis C virus, and he determined that he would not in future accept an award that did not also honour them.

The arduous, multi-year quest to identify hepatitis C, which can be transmitted by blood transfusions, laid the foundation not only for a huge improvement in the safety of the blood supply, but for promising hepatitis C therapies that are now close to the market, as Nature reports this week.

The Gairdner Foundation, like the Nobel Foundation, limits to three the number of scientists who can share an award — a limit that, some argue, is outdated in an age of team science.

Alter, when he stepped to the podium last night, implied as much in a speech that likened the work of research to that of making a movie. Beyond the award winners in the limelight at the Academy Awards, he noted, are “many many more supporting actors who played such critical roles.” (The director of his movie, he said, was undoubtedly his wife, Diane Dowling, even if she never set foot in the lab.)

For a cogent, if opinionated, description on what each of the five men contributed in the quest to track down hepatitis C and screen it in the blood supply, see this Scientific Clearinghouse blog.

FDA lowers age for over-the-counter access to morning-after pill

Posted on 01 May 2013 by Meredith Wadman

The controversial emergency contraceptive Plan B One-Step will be made available without a doctor’s prescription to girls aged 15 and 16, the US Food and Drug Administration (FDA) announced yesterday. The agency also said it would move the pill (levonorgestrel) from behind pharmacy counters to the shelves. That also means that older women will no longer need to find stores where a pharmacist is on duty to obtain the pill, which becomes less effective the longer after sexual intercourse it is taken. Under the new rules, girls under 15 will still need a doctor’s prescription and older women will still need to show proof of age.

The FDA decision comes days before a deadline for the administration of US President Barack Obama to appeal a ruling on Plan B One-Step issued by a New York judge last month. In his 4 April opinion, Judge Edward Korman of the eastern district of New York required the agency to make the pill available without restriction to women of all ages within 30 days. He called a 2011 decision by Obama’s secretary of health and human services, Kathleen Sebelius, to overrule the FDA and deny over-the-counter access to girls under 17 years old “politically motivated, scientifically unjustified and contrary to agency precedent”. Nature has opined about the Plan B issue here and here.

Obama’s Department of Justice would not comment yesterday on whether it intends to appeal. The FDA said that yesterday’s decision responded not to the judge’s ruling, but to an application by Plan B One-Step’s manufacturer, Teva Women’s Health, to make the pill available over the counter to females aged 15 and older. The agency’s announcement states that the decision is “based on an actual use study and label comprehension data submitted by Teva” that showed that the pill could be used properly by girls aged 15 and 16 without a doctor’s help.

Margaret Hamburg, the FDA commissioner said: “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”

Harvard to close troubled primate-research centre

Posted on 24 Apr 2013 by Meredith Wadman

Citing cash concerns, Harvard Medical School announced on Tuesday that it will close the New England Primate Research Center (NEPRC), which houses around 2,000 monkeys in Southborough, Massachusetts.

Jeffrey Flier, the dean of Harvard’s faculty of medicine, said that the decision to close the nearly 50-year-old facility was “made with a heavy heart”. The school’s statement added that the decision was based on a review of the long-term academic benefits and the financial costs of continuing to operate the NEPRC.

The medical school said that in extremely tight budget times, other missions had to take priority and that it will not seek to renew a five-year grant from the National Institutes of Health. Instead, it said, the animals will be transferred to other primate research centres or maintained on site during a 12-to-24 month wind-down period, with a priority on “ensuring the migration takes place with the least possible disruption, and that the scientific work of the NEPRC is continued”. It listed among the centre’s accomplishments the development of the first nonhuman primate models of colon cancer and inflammatory bowel disease, and the first unambiguous evidence that AIDS is caused by a virus.

At least one leader at another of the seven remaining primate research centres supported by the National Institutes of Health was highly critical of the decision. “It’s very, very disturbing, disappointing, disheartening, shocking,” Nancy Haigwood, director of the Oregon National Primate Research Center, told the Boston Globe, which published a detailed blog post about the NEPRC closing on Tuesday.

Animal-welfare groups applauded the decision. It’s “a significant, positive development” said Kathleen Conlee, the vice-president of animal-research issues at the Humane Society of the United States, which issued this statement. “Our government should prioritize alternatives that will provide better, faster and more relevant results for human health.”

The US Department of Agriculture (USDA), which enforces the Animal Welfare Act, has found numerous violations at the Harvard centre in recent years. In March, 2012, the NEPRC suspended new experiments, and its interim director resigned after the third death of a monkey in six months.

“Harvard wants the public to believe that this closure is due to economics,” said Michael Budkie, the executive director of the activist group Stop Animal Exploitation NOW. “That is simply not true. This closure is the direct result of pressure from activists.” Budkie noted that centre is still under investigation by the USDA and could face a substantial fine for multiple violations of the animal-welfare law.

Society for Neuroscience quashing dissent on BRAIN Initiative, critic complains

Posted on 15 Apr 2013 by Meredith Wadman

NIH Director Francis Collins and President Barack Obama announce the BRAIN Initiative at the White House on 2 April.{credit}Chuck Kennedy/White House{/credit}

Fresh from attending President Barack Obama’s announcement of the BRAIN Initiative at the White House on 2 April, Society for Neuroscience (SFN) president Larry Swanson, a neurobiologist at the University of Southern California in Los Angeles, composed this letter to SFN’s nearly 42,000 members.

In the 5 April missive, Swanson, writing on behalf of the SFN’s executive committee, calls the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative “tremendously positive” for neuroscience. Its aim is to let scientists examine and record the activity of millions of neurons as they function at the speed of thought; ultimately, applications to several human diseases are hoped for.

The project comes at a crucial time in neuroscience, Swanson writes: a time of huge new opportunities coupled with stagnant or slumping government budgets for basic science research. (In the budget he released last week, Obama asked Congress to provide about US$100 million to launch the BRAIN Initiative in 2014.)

But the SFN letter makes it clear that Swanson wants a lid put on public criticism of the nascent project, which is expected to last more than a decade and ultimately cost several billion dollars. “It is important that our community be perceived as positive about the incredible opportunity represented in the President’s announcement,” Swanson wrote. “If we are perceived as unreasonably negative or critical about initial details, we risk smothering the initiative before it gets started.”

In case anyone missed the point, he adds that he encourages “healthy debate” and “rigorous dialogue” but urges SFN members to “bring all this to the table through our scientific communications channels and venues”. He also notes that the National Institutes of Health has enlisted a team of “distinguished” neuroscientists to conduct a “rigorous” planning process.

The letter’s admonitions did not sit well with some in the neuroscience community, and on Friday, Avery Gilbert, an olfactory psychologist and author who writes the blog First Nerve posted an entry entitled ‘Society for Neuroscience president: shut up, he explained’.

Gilbert introduced Swanson’s letter, which he posted in its entirety, as follows: “This disgraceful note is what passes for science advocacy today.” He complains that the letter and the views it represents amount to a blatant grab for money: “Swanson wants to suppress open dissent so as not to jeopardize SFN’s rent-seeking activities.”

Today, Nature asked Gilbert, who consults for scent-sensitive industry clients including Colgate-Palmolive and Procter & Gamble as president of Synesthetics, Inc., what he objects to in the BRAIN Initiative itself. He said: “The BRAIN project typifies this administration’s predilection for big government “solutions” flavoured with Chicago-style politics. Central planning rarely works out well, especially not in science.”

Several online commenters agreed with Gilbert’s critique. One wrote: “[Swanson] writes a long letter without any real justification for why the money is needed. How about some results?”

But Larry Goldstein, a prominent Alzheimer’s researcher at the University of California, San Diego, disagrees. “I thought Swanson’s letter was fine,” he says. “Thoughtful, constructive, and optimistic. If we want to see long-term support of scientific initiatives, I think this is the kind of tone that will make the most difference with those who pay the bills, that is, taxpayers.”

Today, Swanson himself told Nature: “My point in the letter was that this project — still very much in its early formative stages — represents a remarkable and perhaps fleeting opportunity… It is my continuing hope that we all reserve judgment on the merits of the broader project until we first learn more about what it will prioritize and fund, and that is going to take some time. If we condemn such a promising investment in neuroscience prematurely, before its focus is known and without engaging scientifically, I firmly believe we will have missed a tremendous chance to advance the field.“

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