A bill that would end invasive research on chimpanzees in the United States is this week the subject of behind-the-scenes negotiations in the US Senate. There, supporters are vying to bring it to an up-or-down vote in the coming days, while opponents are doing all they can to prevent this from happening.

This revised version of the Great Ape Protection and Cost Savings Act is the subject of the maneuvering. It was crafted in recent weeks by Maria Cantwell, the Washington state Democrat who is its primary Senate sponsor.

The revisions are intended to address concerns of opponents of the original bill — concerns that include the costs of  implementing it. Both versions of the bill would require  hundreds of  research chimpanzees to be retired to sanctuaries, with attendant construction costs.  This Congressional Budget Office (CBO) assessment in mid-November put the cost of such a change at $56 million between 2013 and 2017. However, this week the CBO, in a reassessment, says that the newly revised bill would cost the government nothing.

Movement of the bill began this summer, when the Senate Environment and Public Works Committee passed the earlier version.  Among the changes made since then are an extension, from three years to four, of the time during which invasive research on chimps would need to be phased out.  The newly revised bill also allows the great apes to be held  in laboratory housing after the four years elapse, if sanctuary space is not yet available, thus allowing the government to spread sanctuary construction costs over a longer time.

The revised bill also makes it easier for retired chimps to be pulled back into research if an emergency arises. The earlier iteration required a task force to sign off on new research, after considering public comments.  The revised bill gives sole discretion to decide to use chimpaznees in an emergency like a pandemic to the Secretary of Health and Human Services.

However, the heart of the bill — banning invasive research on great apes, whether publicly or privately funded — remains the same, and animal research supporters are still actively opposing it.  The National Association for Biomedical Research (NABR) this week issued this “Urgent Alert” asking supporters to lobby their senators to oppose the bill.  (The alert appears to be reacting to the older version of the bill; NABR could not be reached for comment this afternoon.)

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An embattled agency charged with doling out US$3 billion in Texas taxpayer money for cancer research and prevention has discovered during an audit another unreviewed commercialization grant. The Austin-based Cancer Prevention and Research Institute of Texas (CPRIT) announced yesterday that it has put a hold on the $11-million award and that the company that received it, Dallas-based Peloton Therapeutics, has resubmitted the proposal for commercial and scientific review.

The finding comes on the heels of months of controversy about an $18-million unreviewed grant that went to the University of Texas MD Anderson Cancer Center in Houston.

The award to Peloton, titled ‘Company recruitment, relocation and formation’, was made in June 2010, just six months after the company’s founding, without either scientific or commercial review.  It was among the first commercial grants made by CPRIT.

The company was founded by Steve McKnight, chair of biochemistry at the University of Texas (UT) Southwestern in Dallas. It includes on its board of directors Nobel laureate Michael Brown, the director of UT Southwestern’s Erik Jonsson Center for Research in Molecular Genetics and Human Disease.

CPRIT’s press release yesterday noted that “Peloton was unaware CPRIT processes had not been followed and had played no role in placement of the proposal on the award slate.”

Critics suggested yesterday that the grant is evidence of favoritism by CPRIT to UT Southwestern, which has received many CPRIT grants, and which was the home base of Al Gilman, the Nobel-prizewinning chief scientific officer of CPRIT, who resigned last month in protest over irregular review procedures. Gilman began his job at CPRIT in 2009.

Gilman today protested at the suggestion that he eased the way for the Peloton grant. “I was never sent, and I have not to this day ever seen, the proposal that Peloton sent to CPRIT. The research side of CPRIT had nothing to do with [commercial] review. “

Peloton has also raised $18 million in venture capital financing, which it announced in July 2011.

CPRIT announced last week that Jerry Cobbs, its chief commercialization officer, is resigning, effective today.  In yesterday’s press release, the agency blames Cobbs for the lack of review of the Peloton award, arguing that he “improperly included the Peloton proposal on a commercialization award slate presented to the Institute’s Oversight Committee.”

However, CPRIT’s rules (see page 7) state that executive director William Gimson has final say on which proposals go before the oversight committee for approval. The oversight committee, CPRIT’s governing board, gives final approval to all grant awards.

CPRIT also announced today a change that is not likely to please potential scientific reviewers who are used to an honour system governing peer-review deliberations: an independent third-party monitor will henceforth observe all peer-review meetings and document that the institute’s grant-review policies are followed.

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Animal activists have known for some time that beagle puppies bred in China are regularly shipped to Indian contract research organizations like Bangalore-based Advinus, which uses them for drug toxicity studies, after which the animals are euthanized.

What they didn’t know was how the animals were getting into India. Most major airline carriers now refuse to transport animals bound for research labs, as Nature recently reported (see ‘Lab Animal Flights Squeezed‘).

It emerged last month that in at least one case, the shipper has gotten around this problem by identifying beagles as “pets.” The discovery was made after an activist snapped the above photo of the crates of 70 beagle puppies in Chennai, India, after they landed on 19 October on a Cathay Pacific flight from China. The puppies were being sent to Advinus from Beijing Marshall Biotechnology, a China-based branch of Marshall BioResources of North Rose, New York, a major research beagle breeder. Cathay Pacific has very publicly refused to transport research animals.

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The US National Institutes of Health (NIH) has shelved plans to create a single institute devoted to the study of substance abuse, saying that it will instead maintain two existing, separate institutes that are devoted to studying, respectively, drug addiction and alcohol abuse.

The NIH director, Francis Collins, announced in a statement today that “after rigorous review and extensive consultation,” he has opted not to pursue a proposed dissolving of the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism. The two institutes, with respective budgets of $1 billion and $459 million, would have been replaced by a single, substance use, abuse and addictions institute. Instead, Collins, said, he will seek “functional integration” of the two existing institutes’ work, along with related research housed in the agency’s 25 other institutes and centres.

Nature examined the proposal for a single addictions institute in-depth in this news article, “Plan for Addiction Institute Splits NIH.”  That article was published shortly after a board that advises Collins on major structural changes at NIH recommended, on a vote of 12-3, that the single institute be established.

Today, Collins said that the time, energy and resources that would be needed to enact a major structural reorganization were not warranted in a time of fiscal duress for the agency. He added that the same ends could be achieved by better coordination of addiction-related work among all existing NIH institutes.

The decision represents an about-face for Collins, who told his committee of external advisers in June: “The goal at the moment is to aim to launch this new institute at the start of [fiscal year] 2014, on October 1 2013.”

At the June meeting Collins also noted, “We have heard from leaders in the alcoholic beverage industry and they are concerned about this new institute.” The opposition suggests the industry was uncomfortable with a research entity that would more closely link public perceptions of alcohol consumption and abuse with drug addiction.

Another factor may have played into the decision: NIH’s launch in January of the new National Center for Advancing Translational Sciences, and the attendant dissolution of the agency’s National Center for Research Resources. The reorganization had generated controversy at NIH (See “NIH Revamp Rushes Ahead.”) and with that experience fresh in mind, the agency’s leaders may have lost their appetite for further major structural change so soon.

To get a sense of the split engendered at NIH by the proposal to establish a single addictions institute, consider the reactions to the proposal, two years ago, from two former directors of the relevant institutes:

“It makes infinite scientific sense. There’s no question that these are all drugs of abuse and addiction and they should be treated together, dealt with together.”

–Alan Leshner, who directed NIH’s drug abuse institute from 1994 to 2001

“It’s a terrible idea. This is not a meeting of equals. This is one institute trying to take over another.”

–Enoch Gordis, director of the NIH’s alcohol abuse institute for 15 years, until 2001

Should a sick person in the United States have to pay US$9.18 for an anti-AIDS pill when a Canadian is paying $1.16 for the same tablet, and a New Zealander $1.15?

Four consumer and medical groups led by Washington, DC-based Knowledge Ecology International are asking the US National Institutes of Health (NIH) to say no to that question. On 25 October, they petitioned the agency to exercise a never-used legal privilege known as a ‘march in right’ to grant open licences to would-be makers of the protease inhibitor Norvir (ritonavir), now marketed exclusively by Abbott Laboratories.

March in rights are part of the Bayh-Dole Act, a landmark 1980 US law that aimed to spur the commercialization of government-funded inventions and helped to launch the biotechnology industry. The law says, in part, that the NIH can ‘march in’ and force open licensing of an invention it funded when the exclusive license-holder, in this case, Abbott, is not taking adequate steps to “achieve practical application” of the invention. (See section 203 of the Bayh-Dole Act here.) The NIH funded Norvir’s discovery by a scientist then at Abbott.

That language covers the situation where a licensee simply sits on an invention and doesn’t develop it, but the law also defines “practical application” to mean that the invention’s benefits are “to the extent permitted by law or Government regulations available to the public on reasonable terms” (see section 201 of the Bayh-Dole Act).

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