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News the US Supreme Court Rules on Liability for Drug Labelling For the full versions of articles in this section see bmj.com UK NEWS Government removes data sharing clause from coroners’ bill, p 618 NEWS WORLD NEWS Target to reduce child mortality is under threat from diarrhoea, p 620 bmj.com Tobacco atlas illustrates shift to low income countries Five academic health science centres are announced in England Zosia Kmietowicz LONDON The health secretary, Alan Johnson, announced on 9 March that five academic health science centres are to be created in England, after peer review of the seven final applicants by an international panel. The successful centres are Cambridge University Health Partners, Imperial Col- lege, King’s Health Partners, Manchester AHSC, and University College London /AP/PA Partners. Bids from Oxford and Birmingham T were unsuccessful. In July 2007 the junior health minister Ara TALBO TOBY Darzi had called for the establishment of aca- Diana Levine lost her livelihood as a musician after her forearm was amputated demic health science centres in England in his strategy for the future of the NHS, High Quality Care for All, to speed up the process The US Supreme Court rules of applying breakthroughs in research to the care of patients. It is hoped that the centres—partnerships on liability for drug labelling between universities and leading NHS Janice Hopkins Tanne The Supreme Court’s ruling forearm amputated after an organisations—will be better able to com- NEW YORK means that other people intramuscular injection of pete globally with established centres such The US Supreme Court has who believe they have been promethazine. The drug was as those in the United States, Canada, ruled that the drug company injured by a drug can sue the given by the “IV push” method Singapore, Sweden, and the Netherlands. It Wyeth was liable for $6.7m manufacturer even where directly into a vein and either is envisaged that the centres of excellence (£4.7m; €5.3m) in damages the drug’s labelling has been penetrated an artery or leaked will be well placed to compete on the world in a lawsuit brought by Diana approved by the FDA. The into surrounding tissue. stage for talent and funding, drawing in eco- Levine, a guitarist from Vermont. number of such suits is likely In her lawsuit Ms Levine nomic benefits for the United Kingdom as Ms Levine’s right forearm to increase and may lead said that the labelling should a whole. was amputated because of companies to strengthen have told doctors to use IV drip Mr Johnson said, “I congratulate the gangrene caused by an injection warnings in their drug labelling. administration instead of the successful candidates, who have demon- of Wyeth’s drug promethazine Ms Levine sued Wyeth in higher risk IV push method. strated their enthusiasm and commitment hydrochloride (Phenergan). She Vermont courts under a product Wyeth said that the decision to the vision of bringing together world said that the drug’s label did not liability law, saying that Wyeth’s was “disappointing, not only class research, teaching, and patient care to sufficiently warn of its risks. labelling of the drug did not for Wyeth, but for patients and improve health in local communities as well Wyeth had argued that sufficiently warn of risks. A jury public health in general. Patients as internationally through their global reach. because the drug’s labelling found in her favour. are best served by a national NHS patients will reap the benefits of the had been approved by the US Wyeth appealed, saying standard for the labelling of work of these new centres. Food and Drug Administration that the FDA had approved prescription medications set “In times of economic uncertainty it is it was protected from lawsuits the drug’s labelling and states by the medical and scientific even more important that we continue to brought in state courts, as could not require stronger experts at the FDA.” support this country’s knowledge industries Ms Levine’s was. Federal law warnings. It said that the label The company also said that it to ensure that we benefit from the competi- usually pre-empts state law. clearly warned of the danger had provided clear instructions tive edge which they provide.” Justice John Paul Stevens, of gangrene and amputation about using the drug, including The centres will retain their academic sta- who wrote the court’s opinion, from inadvertent intra-arterial the risk at issue. tus for five years, after which they will have said that drug makers, not the injection. The Supreme Court’s decision is to reapply. FDA, are primarily responsible Ms Levine developed at www.supremecourtus.gov. Cite this as: BMJ 2009;338:b1005 for their drug labelling. gangrene and had her right Cite this as: BMJ 2009;338:b964 See NEWS, p 623 BMJ | 14 MARCH 2009 | VOLUME 338 617 NEWS Prominent celecoxib researcher admits fabricating data in 21 articles Jeanne Lenzer NEW YORK of Medicine, said that after evaluating the 51 James Eisenach, editor in chief of A well known researcher who promoted the use other articles by Dr Scott the centre “was not able Anesthesiology, said that Dr Reuben’s research of the non-steroidal anti-inflammatory drug to reconstruct the scientific trail” to either prove or was central to the claim that celecoxib reduces celecoxib has admitted fabricating data in 21 of disprove fraud in those articles. pain at six and 12 months after surgery. He said his 72 articles indexed by PubMed. The case is The notice says that “all fabricated data were that the fraud creates a “hole” in pain research “among the biggest which has come to light,” said created under the sole control of Dr Reuben.” and casts doubt on claims about celecoxib. Harvey Marcovitch, chairman of the Committee Dr Reuben, who received research grants Dr Eisenach says in an editorial to on Publication Ethics, an international forum for from Pfizer, the US manufacturer of celecoxib be published in the May 2009 issue of publishers and editors of peer reviewed journals. (marketed as Celebrex), and served on its Anesthesiology (http://pdfs.journals.lww.com/ Scott S Reuben, chief of the acute pain service speakers’ bureau, pioneered “multimodal anesthesiology/9000/00000/99939.pdf) that at Baystate Medical Center in Springfield, analgesia,” the combination of celecoxib the retracted articles “have been considerably Massachusetts, has admitted the fraud, says with another Pfizer drug, the anticonvulsant cited since 2002” and that mere retraction of a notice issued by the centre. Jane Albert, a pregabalin (Lyrica). The combination, Dr Reuben the articles will not be enough. He says that spokeswoman for the centre, a teaching hospital claimed, was preferable to opioids, and it became the journal will use its peer review system “to that serves as a campus of Tufts University School a mainstay in pain management. assure that these articles are no longer cited by Obama reverses US federal ban Government removes data sharing clause on funding stem cell research from coroners’ bill Janice Hopkins Tanne NEW YORK two are not inconsistent. “As a person Zosia Kmietowicz LONDON President Barack Obama has of faith, I believe we are called to Jack Straw, the UK justice secretary, is to removed the ban introduced care for each other and work to abandon plans that could have allowed by the previous US president, ease human suffering. And many patients’ medical records to be used by third George Bush, on using federal thoughtful and decent people parties without patients’ consent. funds to support embryonic stem are conflicted about, or strongly A spokeswoman for the Ministry of Jus- cell research, in an executive order oppose, this research . But tice said that the government still believed issued this week. after much discussion, debate, strongly in data sharing but had accepted Government support will now be and reflection, the proper course the concerns of many critics that clause 152 available for research with many more has become clear. The majority of the Coroners and Justice Bill was not the stem cell lines than previously. These lines of Americans—from across the way forward. are developed from surplus embryos that political spectrum and from of all Although the aims of the clause, which remain after fertility treatment; the backgrounds and beliefs—have come would allow data to be shared among embryos would otherwise have been to a consensus that we should pursue government departments so that it was easy stored indefinitely or destroyed. this research, that the potential it offers to identify, for example, children who were President Obama said that human cloning is great, and with proper guidelines and strict entitled to free school meals, were good would never be permitted and that research oversight the perils can be avoided.” “there are some justifiable concerns that the would proceed under strict guidelines to In August 2001 President Bush banned powers could have been misused,” she said. be developed by the National Institutes of federal support for research on stem cells Mr Straw would be launching a consulta- Health over the next four months. except for 21 stem cell lines already created. tion on “how data can be shared in a way The order does not provide funding to Scientists found that many of these stem cell that is safe,” she said. “We want a system so create new embryonic stem cell lines because lines were contaminated or not useful (BMJ that no one has anything to fear.” of a ban called the Dickey-Wicker amend- 2001;323:357). A BMA spokesperson said, “We think it’s ment. This prevents using federal funds to Private funding of stem cell research was vital for the doctor-patient relationship that create human embryos for research in which permitted.
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