Psychiatrist accuses university of ghostwriting ‘whitewash’

The University of Pennsylvania psychiatrist who last year alleged that his colleagues had allowed their names to be added to an influential manuscript that had been ghostwritten by authors paid by a drug company said today that the university “whitewashed” their behaviour in a subsequent investigation that found the psychiatrists to be rightful authors of the paper.

On 26 June, their accuser, Jay Amsterdam, filed a 24-page complaint with the Office of Research Integrity at the US National Institutes of Health, asking that the office undertake “a more thorough and complete” investigation of the matter than did the Ivy League university.

The findings of an investigation by the university’s Perelman School of Medicine were made public in March. As Nature reported (see ‘University clears psychiatrists of misconduct‘),  the investigation found that the two university authors, Dwight Evans, who is the chairman of psychiatry at the university, and Laszlo Gyulai, now a retired associate professor of psychiatry, broke no rules that were in place when the widely cited 2001 paper was prepared and published in the American Journal of Psychiatry.

The publication, about the antidepressant drug Paxil (paroxetine), failed to acknowledge a medical-writing company paid by the drug’s maker, GlaxoSmithKline (GSK), to help prepare the manuscript. It also failed to acknowledge that three of the other authors were GSK employees at the time the study was conducted.

In today’s complaint, Amsterdam says that the university “went out of its way to find a path to whitewash the conduct of its employees”.

Amsterdam contends that the investigating committee failed to obtain and examine important documents from Scientific Therapeutics Information, Inc., the scientific writing company employed by GSK. He writes:

“The University intentionally chose not to obtain and examine important documentary evidence it was aware existed from the files of the ghostwriting firm, STI, which would have provided the Committee highly relevant information not otherwise available to them. The Inquiry Committee relied on the word of the two University of Pennsylvania Respondents as factual, while the unexamined STI documents appear to contradict the Respondents’ testimony.”

Amsterdam also argues that the investigators should have interviewed the paper’s other co-authors.

“By choosing not to obtain the testimony of the other respondents named in the case, we believe the Inquiry Committee lost the opportunity of obtaining important information that may have corroborated (or called into question) the testimony provided to the Committee by Dr. Evans and Dr. Gyulai.”

Susan Phillips, senior vice-president at Penn Medicine, the governing board that oversees the medical school, said today that “no facts have changed” since the investigation was completed. “We are standing by our original statement,” she added, referring to the announcement the university made in March when the investigation’s results were publicized.  It says, in part:

“There was no plagiarism and no merit to the allegations of research misconduct. Drs. Evans and Gyulai satisfied all authorship criteria and the publication presented the research findings accurately.”

Gyulai declined to comment on the letter. At the time of this story’s publication , the other academic authors on the paper had not respond to e-mail requests for comment.

Israeli airline stops transporting research primates

The Israeli airline El Al has added itself to the list of air carriers refusing to transport monkeys for medical research.

In this June 18 letter, a spokesman for El Al writes: “El Al will not fly monkeys meant to be used for experiments. Period.” (An English translation of the letter is available here.)

The letter, to Jonathan Shpigel, a lawyer with the Israeli animal-advocacy group Let the Animals Live, follows an Israeli Supreme Court ruling earlier this month that is covered in detail in this article in the Israeli newspaper Haaretz.

In the ruling, the country’s high court said that an Israeli breeding facility could not export wild-caught monkeys to the United States, although it could continue to export captive-bred animals. The B virus Free Cynomolgus (BFC) monkey Breeding Farm near Tel Aviv — popularly known as Mazor Farm — had planned to ship 50 wild-caught animals to Shin Nippon Biomedical Laboratories in Everett, Washington, along with 40 captive-born macaques.

However, Mazor Farm had been relying on El Al to do the shipping.

After the Supreme Court decision, activists worldwide, including People for the Ethical Treatment of Animals, mounted an intense campaign  to pressure El Al not to ship the remaining animals. On 18 June, El Al wrote the letter to Shpigel saying that it would no longer transport monkeys.

A similar commitment to stop transporting research primates had been made by El Al in this letter of October 2010. This time, says Shpigel, “The significant thing would be if they would stick to it.”

Neither El Al officials nor a lawyer for Mazor Farm could be reached for comment on Friday afternoon in Israel. This blog will be updated with any responses that the airline or the breeder provide in the coming days.

Shin Nippon Biomedical Laboratories was also affected in February when activists grounded an Air France flight of 60 monkeys bound from Mauritius to the US facility.

Image credit: Adrian Pingstone

NIH receives key reports on diversity and biomedical workforce

Raising the minimum salary for postdoctoral researchers and capping at six the number of years a graduate student can be funded by the US National Institutes of Health (NIH) are among the recommendations of a report that aims to tackle a key challenge for NIH and American biomedical science: an oversupply of young scientists for whom tenure-track jobs are becoming  increasingly difficult to obtain.

The long-awaited draft report from the Biomedical Research Workforce Working Group was presented on 14 June to NIH director Francis Collins and his expert advisory committee. A second draft report, from the Working Group on Diversity in the Biomedical Research Workforce, was released at the same time. The second report addresses the plight of under-represented minorities in biomedical science, as exemplified in this report in Science last August. It showed that, all other things being equal, an African American scientist remains ten percentage points less likely than a white applicant to be awarded NIH research funding.

Advisory-committee members will provide Collins with feedback on the reports in the coming weeks. Collins promised to report back to the committee at its December, 2012 meeting, telling them which of the reports’ recommendations he is adopting, and how.

A briefer, executive summary of the workforce report is available here. An executive summary of the diversity report can be seen here. Nature will publish a more detailed look at both reports in the coming days.

Abandoned drug effort picks up steam

Five more big pharmaceutical companies have joined a nascent effort by the US National Institutes of Health (NIH) to find new uses for drugs that have been shelved by industry.

Contributions of clinic-ready drugs from the companies — Abbott, Bristol-Myers Squibb Company, GlaxoSmithKline, Janssen Pharmaceutical Research & Development and Sanofi — will bring to 58 the number of compounds that will be available to academic scientists to try to redirect to new purposes, NIH says in a news release. The drugs were abandoned by their developers for strategic reasons or because they simply didn’t work. They have had millions of dollars invested in them and have been shown to be safe in phase I trials.

The programme, the first major initiative of the NIH’s new National Center for Advancing Translational Sciences (NCATS), was launched six weeks ago with contributions of some two-dozen drugs from Pfizer, AstraZenca and Eli Lilly. Nature has written about Discovering New Therapeutic Uses for Existing Molecules in detail.

Information about the available compounds, including their mechanisms of action, route of administration, and the disease they were originally developed to treat, can be perused here.

The NCATS will make up to US$20 million available to fund awards under the programme in 2013.  Pre-applications responding to this announcement are due by 14 August.

 

Texas cancer institute adds scientific review of controversial grant

The Cancer Prevention and Research Institute of Texas (CPRIT) announced yesterday that it will add scientific reviewers to those  revisiting a controversial, $18 million grant.

The technology “incubator” grant, which directed $18 million to the Institute for Applied Cancer Science (IACS) at MD Anderson Cancer Center in Houston, has aroused a firestorm of controversy.  The 6.5 page proposal was speedily approved in March by CPRIT’s Commercialization Review Council, without input from the institute’s  scientific peer reviewers. At the same time, $39 million of research grants recommended for funding by CPRIT’s scientific peer reviewers were not funded.   The principal investigator on the incubator grant is Lynda Chin, the chief scientist at IACS and  the wife of MD Anderson president Ronald DePinho.

Last week, after DePinho wrote to CPRIT offering to have the grant reassessed, CPRIT said its commercial reviewers would re-review it.   Yesterday, CPRIT executive director William Gimson announced that scientific review of the grant would be included in that process.

“Hindsight is 20/20,”  Gimson said in an interview with Nature today. “At the time [the incubator grant process was launched] we felt the incubator would have a sufficient review under the Commercialization Review Council.” Given the subsequent controversy, he added “We want to hold ourselves to a higher standard. So we are willing to come back and say: `If these questions have been raised, let’s have a scientific and a commercial review.'”

Gimson said that a single, merged panel of 12 to 16 reviewers will be constituted, half selected by the chair of CPRIT’s Scientific Review Council, and half by the chair of the Commercialization Review Council.  They will be likely to re-review the  MD Anderson grant in September or October, after a revised Request for Applications is released this summer.

Here is the full text of  the statement that Gimson released yesterday, which also says that CPRIT is convening a “future directions” working group to recommend how to shape its prevention, research and commercialization agendas going forward:

The commercialization review of MD Anderson’s Institute for Applied Cancer Science (IACS) portion of the Houston Area Incubator proposal followed the policies and procedures approved by our Oversight Committee. However, last week MD Anderson offered to resubmit the IACS portion of the Houston Area Incubator proposal for additional review, and CPRIT has accepted that offer. The re-review of the IACS proposal will entail a joint scientific and commercialization review.

 Any changes to CPRIT’s incubator review policy will be applicable to all incubator applications approved by CPRIT. For this reason, amendments to the incubator RFA guidelines will be brought before CPRIT’s Oversight Committee in July.

 Additionally, CPRIT is commissioning a statewide workgroup to review and make recommendations for the future directions of its prevention, research and commercialization programs. For more information on this workgroup and steps CPRIT is taking to ensure continued quality and transparency in all its operations, please visit https://www.cprit.state.tx.us/about-cprit/future-directions-workgroup/ .

 

Texas cancer-centre head apologizes for promoting stock on television

The president of the MD Anderson Cancer Center in Houston, Texas, already embroiled in a grant funding controversy involving his wife, promoted the sliding stock of a cancer-drug company he co-founded in an appearance on the CNBC cable television channel on 18 May.

The Cancer Letter broke the news on 1 June about Ronald DePinho’s appearance on “Closing Bell with Maria Bartiromo”. DePinho’s appearance on the show, which many viewers watch for stock-buying tips, came ten days after it was revealed that Alfred Gilman, the Nobel prize-winning lead scientist at the Cancer Prevention and Research Institute of Texas (CPRIT), was stepping down from his position.  In his resignation letter, Gilman cited concerns over a speedy, US$18-million award to a team led by Lynda Chin, an MD Anderson cancer scientist who is married to DePinho. (It now emerges that Gilman was urged towards the door by senior CPRIT management. See below.)  Because the award to Chin and her team was made under the institute’s commercialization portfolio, it was not scientifically reviewed but assessed by CPRIT’s Commercialization Review Council.  DePinho and Chin defended the award and the process in interviews with Nature published yesterday, the same day that CPRIT announced that the award will be re-reviewed.

Watch the CNBC interview below:

DePinho’s comments lauding the company, Aveo Pharmaceuticals, in which he and his family trust own 590,440 shares, come in the middle of the interview and are as follows: Continue reading

Texas cancer institute to re-review controversial grant

Ronald DePinho and Lynda Chin

The largest grant to date from one of the world’s major institutional funders of cancer research will be re-reviewed, officials overseeing the award now say, even as the grant’s high-profile recipients steadfastly assert the money was fairly awarded and would be well spent.

The Texas cancer world has been rocked by controversy since the 8 May resignation of Alfred Gilman, a Nobel laureate and chief scientific officer at the US$3-billion, taxpayer-funded Cancer Prevention and Research Institute of Texas (CPRIT) in Austin.

In leaving, Gilman cited his concerns about an $18-million “incubator” grant speedily awarded in March, without scientific review, to a team at the Institute for Applied Cancer Science (IACS) at MD Anderson Cancer Center in Houston.

The controversial grant’s purpose is to build infrastructure that will speed the development of cancer drugs by, among other things, expanding the small-molecule pipeline to include biologics, and boosting current target biology and small molecule discovery efforts. (Rice University in Houston, a partner with the IACS, would receive $2 million as part of the same award.)

Lynda Chin, the cancer researcher who was listed as principal investigator on the IACS team, is the IACS scientific director and is also married to MD Anderson president Ronald DePinho. The couple moved to the huge institution last August from the Dana-Farber Cancer Institute in Boston, Massachusetts. At that time the lines of authority governing Chin’s reporting, potential promotions and salary were outlined in this e-mail to her and DePinho from Kenneth Shine, the executive vice-chancellor of health affairs for the University of Texas system.

In his resignation letter, Gilman complained that the CPRIT had in March sidelined seven scientific grants that had already been reviewed and recommended and were worth $39 million.  He added that he would stay on in the job for several months “to champion the research slate” and “to prevent further award of vast funds for research programs ostensibly within incubators that were not described and therefore could not have been reviewed.”  A subsequent letter to the CPRIT oversight committee from its scientific-review council, headed by biologist Philip Sharp of the Massachusetts Institute of Technology, called the 6.5-page incubator proposal from Chin and colleagues “research,” even if “strikingly lacking in specific[s]”. “We are surprised and disappointed by the failure of proposals of this sort to receive scientific (research) peer review,” the committee wrote.

The CPRIT’s decision to re-review the grant emerged during a quick exchange of letters in which DePinho offered to have it vetted again and William Gimson, CPRIT executive director, agreed to take up the offer in his same-day response.  However, Gimson’s letter makes clear that, as with the first review, it will be conducted by the CPRIT commercialization review council — the panel that passed muster on it the first time — and not by scientific reviewers.

DePinho and Chin both agreed to speak with Nature yesterday. Here is a condensed version of their remarks:

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Senate watchdog questions US grant to controversial psychiatrist

A senior US senator today asked the National Institutes of Health (NIH) to explain its decision earlier this month to award a five-year grant worth up to US$2 million to a psychiatrist who is now under investigation by the US Department of Justice and who failed to report more than $1 million in pharmaceutical-company income in the past.

In this letter, first obtained by the blog Pharmalot, Senator Charles Grassley, a Republican of Iowa, tells NIH director Francis Collins that it is “troubling that NIH continues to provide limited federal dollars to individuals who have previously had grant funding suspended for failure to disclose conflicts of interest.”

The new grant was awarded to Charles Nemeroff (pictured), the chair of psychiatry at the University of Miami in Florida, on 16 May, as Science Insider first reportedAccording to the NIH grants database, Nemeroff — who did not reply to e-mails over several days requesting comment — will use it to study the psychobiological risk factors for post-traumatic stress disorder.  The grant, from the National Institute of Mental Health (NIMH), is worth $401,675 in 2012 and will run for 5 years. Nemeroff has previously been punished for failing to report at least $1.2 million in pharmaceutical-company income.  That episode also led to a still-open US justice-department investigation of Nemeroff that is being conducted in conjunction with the Inspector General of the Department of Health and Human Services, the parent agency of the NIH.

Near the top of a list of six hard-hitting questions in the letter to Collins, Grassley asks: “Was NIH aware that Dr. Nemeroff was under federal investigation? If so, why did NIH decide to award this grant anyway?”  He adds: “Were the peer reviewers aware that Dr. Nemeroff was under federal investigation? If not, why not? Provide pertinent documents.”

In the letter, Grassley also hammers the NIH for failing to require that universities create public websites reporting on the amounts and nature of any financial conflicts of interest for their NIH-funded scientists. The agency has previously said that it would institute such a requirement when it released revamped conflict-governing rules, but it backed off from that proposal last August, and the NIH’s final rules on the matter said that institutions that choose not to establish a website can instead respond to written requests for such information from members of the public.

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Europe targets superbugs with public–private effort

The growing threat from antibiotic resistance met the era of the public–private partnership on 24 May, as the European Union’s  Innovative Medicines Initiative (IMI) launched a new seven-year effort to bring academic and industry researchers together to work on the problem.

Dubbed NewDrugs4BadBugs, the call for proposals is supported by a budget of €223.7 million (US$280 million), with roughly half of the money to come from the IMI and the remainder from companies GlaxoSmithKline, AstraZeneca, Janssen, Sanofi and Basilea Pharmaceutica. Their contributions will include scientific expertise, clinical-trial managers and the drugs themselves. As the programme progresses, it could eventually disperse some €600 million to researchers working to develop new antibiotics.

The programme is part of the Action Plan Against the Rising Threats from Antimicrobial Resistancea strategy announced by the European Commission late last year to fight the rise of drug-resistant ‘superbugs’, from harmful strains of Escherichia coli to methicillin-resistant Staphylococcus aureus, or MSRA (pictured).

Initially, the programme will focus on improving clinical-trial design and learning from past successes and failures. Proposals from prospective applicants are due by 9 July 2012, with more solicitations to follow during 2012–13. The ultimate aim: to boost a pipeline of new antibiotics that the World Health Organization has called “virtually dry”.

Sponsors say that the programme will encourage participants to share information — including what hasn’t worked in past — to avoid duplication and  improve clinical trials, making them more rational and targeted.

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US strategy for Alzheimer’s disease laid out

The US government today released its first strategic plan for battling Alzheimer’s disease, the progressive, incurable dementia that afflicts more than 5 million Americans.

Speaking at a large Alzheimer’s research summit on the campus of the US National Institutes of Health (NIH), Kathleen Sebelius, the US Secretary of Health and Human Services, called the 59-page National Plan to Address Alzheimer’s Disease “a blueprint for building on our research efforts” and “a road map that will help us meet our goal to effectively prevent and treat Alzheimer’s disease by 2025.”

Sebelius also promoted a new website that the department is launching as a “one stop shop” offering resources and support for patients with Alzheimer’s and their families and caregivers.

The plan was mandated by the National Alzheimer’s Project Act, which was signed into law by President Barack Obama in January 2011. The law directed a 25-member advisory committee to come up with the plan, which was released in draft form early this winter.  Nature published this interview with Ronald Petersen, the Mayo Clinic Alzheimer’s expert who heads the committee, shortly after the draft was released.

Today’s final plan, which deals with quality of care, community support and public awareness — in addition to research — is substantially unchanged from the draft, but that didn’t dampen enthusiasm on the NIH campus.

“We’re very excited about seeing how this exceptional moment can be utilized,” said Francis Collins, the NIH director.

The research elements in the plan are not surprising. They include suggestions that international research be coordinated to avoid duplication; that clinical trials on both prevention and treatment be expanded; and that trials include more ethnic and racial minorities.

Collins fleshed out how the NIH will use the US$50 million in current-year funds that it has redirected to research on Alzheimer’s as part of the administration’s new emphasis on the disease.  He and Sebelius had already announced the 2012 Alzheimer’s money in February, noting, as Nature reported then (see ‘Graying US boosts Alzheimer’s research‘)  that about $25 million will be used to sequence the genomes and exomes of people afflicted with Alzheimer’s and of unaffected individuals, to identify both risk factors and protective genetic variants.

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