Press releases Monday 39 March to Friday 2 April 2010

Please remember to credit the BMJas source when publicising an article and to tell your readers that they can read its full text on the journal's website (http://www.bmj.com).

(1) Experts call to end secrecy surrounding approval of new drugs
(2) Father of Lockerbie victim backs Megrahi's 'compassionate release'
(3) Will genetics ever have the promised impact on medical practice?
(4) Treatment checklists may cut hospital deaths

(1) Experts call to end secrecy surrounding approval of new drugs
(Analysis: Europe's opportunity to open up drug regulation)
http://www.bmj.com/cgi/content/extract/340/mar30_2/c1578

Changes are urgently needed to end the secrecy surrounding approval of new drugs in Europe, argue experts on bmj.com today.

Questions about the benefits of the flu drug oseltamivir in otherwise healthy people have fuelled debate about the secrecy surrounding the documentation submitted by drug companies to obtain approval of new drugs, write Silvio Garattini and Vittorio Bertele' from the Mario Negri Institute for Pharmacological Research in Italy.

They believe that greater transparency "would open drug dossiers to evaluation by the scientific community and help independent interested parties define the benefit-risk profile of new medicines before they are allowed on to the market."

And they suggest that the recent movement of the European Medicines Agency (EMA) to the Health and Consumer Policy Directorate (DG Sanco) rather than the Enterprise and Industry Directorate "presents an opportunity to introduce more openness."

The industry considers it has the right to secrecy, in order to protect the substantial investments made to develop a new drug. But the authors argue that the public is an "essential partner" in new discoveries and therefore has "the right of access to all relevant information."

Secrecy about clinical data "implies undue exploitation of the rights of doctors and patients participating in the studies," they say.

Transparency of the regulatory system is also required "to overcome several dysfunctions in the drug industry’'s behaviour" and "cast light on deviations from trial protocols," they add.

The abolition of confidentiality would help make the system more transparent and enable clinicians and patients' representatives to obtain information on which to base constructive criticism, establishing public confidence and improving research in the industry itself, they explain.

Abolition of secrecy by EMA would also boost the regulatory authorities' credibility and show that patients' health has priority over industrial interests, they conclude.

Contact:
Silvio Garattini, Director of Pharmacology, Institute for Pharmaceutical Research, Milan, Italy
Email: silvio.garattini@marionegri.it

(2) Father of Lockerbie victim backs Megrahi's 'compassionate release'
(Personal View: Lockerbie - why we should be proud of Megrahi's doctors)
http://www.bmj.com/cgi/content/extract/340/mar30_2/c1725

A retired GP and father of a Lockerbie victim is publicly supporting the medical advice given to Kenny MacAskill, the Scottish justice secretary, that led to the release of Abdelbaset al-Megrahi on compassionate grounds in August 2009.

Dr Jim Swire, who met Mr Megrahi in prison, has decided to speak out following allegations in the media that, now he has survived for seven months, his illness was fabricated or at least exaggerated for some political or economic motive and that the doctors must have been "bought."

His views are published on bmj.com today.

Mr Megrahi was convicted of the bombing of Pan Am flight 103 as it flew over Lockerbie in December 1988. After the failure of his first appeal in 2002, he was transferred to a Scottish prison, but public opinion about the verdict remains deeply divided.

By August 2009, medical advice indicated that Megrahi, who has prostate cancer, only had three months left to live, and he was granted "compassionate release" by the Scottish justice secretary to return to his home in Tripoli.

"There were shouts of fury from those who had not looked at the evidence for themselves," recalls Swire. "Some of these were the same voices who had urged that analgesics should be withheld from the suffering prisoner; one wrote to me that he hoped Al-Megrahi's death would be a long drawn out agony."

But he explains that MacAskill took advice from the prison medical service in Greenock prison as well as several senior doctors who "conferred before advising MacAskill that a likely prognosis for Al-Megrahi was about three months."

He also points out that the two major changes in Al-Megrahi's circumstances since his release - returning home to his family and receiving drug treatment together with radiotherapy - might well explain the dramatic and welcome improvement in his condition.

"I wish to support the advice that my distinguished medical colleagues gave to MacAskill," says Swire. "By sticking to their patient oriented professional duty, the doctors contributed to a major relief for a dying man. We should be proud of them."

He concludes: "When I last met this quiet and dignified Muslim in his Greenock cell he had prepared a Christmas card for me. On it he had written, "To Doctor Swire and family, please pray for me and my family." It is a treasured possession by which I shall always remember him. Even out of such death and destruction comes a message of hope and reconciliation for Easter."

Contact:
Jim Swire, retired GP (and father of Flora, a Lockerbie victim)
Email drjimswire@aol.com

(3) Will genetics ever have the promised impact on medical practice?
(Head to Head: Is modern genetics a blind alley?)
Yes: http://www.bmj.com/cgi/content/extract/340/mar30_2/c1156
No: http://www.bmj.com/cgi/content/extract/340/mar30_2/c1088

Since the discovery of gene sequencing in the late 1970s, it was predicted that genetics would revolutionise medicine and provide answers to the causes of many of our common killers. But has genetic research delivered its promise? Experts debate the issue on bmj.com today.

London GP, James Le Fanu argues that the influence of modern genetics on everyday medical practice "remains scarcely detectable."

Nearly 10 years have elapsed since the completion of the first draft of the human genome project, he writes. Although there have been substantial achievements and fascinating insights, the prevention and treatment of genetic disorders remains as elusive as ever.

He suggests that genetic research "has forcibly drawn to our attention our ignorance about the most elementary aspects of gene function," and it is therefore "highly improbable that the future of medicine might lie in understanding disease at the most fundamental reductionist level of the gene and the proteins for which they code."

This takes us to the end of the alley, he concludes. "There is no way out, and the sooner we recognise it the better because the current dominance of medical genetics threatens to bury the true spirit of intellectual inquiry under an avalanche of undigested (and indigestible) facts."

But Professor David Weatherall from the Institute of Molecular Medicine at the University of Oxford disagrees.

He explains that mutations for hundreds of single gene (monogenic) diseases have now been identified and, "although gene therapy for their correction has proved difficult, sufficient progress has been made to suggest that this approach will be possible in the future."

Spectacular advances have also followed the application of molecular biology to communicable diseases and cancer, he adds.

"These examples of the medical applications of molecular genetics, all of which are still progressing in many different directions, certainly do not suggest that modern genetics has reached a blind alley," he writes.

He concludes: "The remarkable advances that are occurring in evolutionary and developmental biology, and the highly original approaches to tackling the problems of biological complexity ... show that viewing the young discipline of genetic research as a blind alley would be short sighted."

Contact:
James Le Fanu, General Practitioner, Mawbey Brough Health Centre, London, UK
Email james.lefanu@btinternet.com
D J Weatherall, Regius Professor Emeritus, Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, UK
Email liz.rose@imm.ox.ac.uk

(4) Treatment checklists may cut hospital deaths
(Quality Improvement Report: Using care bundles to reduce in-hospital mortality: quantitative survey)
http://www.bmj.com/cgi/content/full/340/mar31_3/c1234

Patient deaths at three London hospitals have been cut by almost 15% after introducing treatment checklists (known as care bundles), finds a study published on bmj.com today.

The researchers say their methods could be used to reduce mortality in many other hospitals.

The North West London Hospitals NHS Trust serves a population of about 500,000 at three sites: Northwick Park Hospital, Central Middlesex Hospital and St Mark's Hospital. In 2005 and 2006, the trust was subject to a series of adverse media stories which impacted on staff morale and also on patients' perceptions of care.

So a group of senior clinicians set out to reduce hospital inpatient mortality and thus increase public confidence in the quality of patient care at the trust.

They developed eight care bundles for 13 diagnostic areas with the highest number of deaths at the trust in 2006-7. These included treatments for stroke, heart failure and chronic obstructive pulmonary disease (COPD).

Care bundles are a collection of treatment checklists based on clinical guidelines that, when combined, improve the effectiveness and safety of patient care.

Adjusted hospital mortality for 2007-8 (the year the care bundles were introduced) was then compared with the previous year using the hospital standardised mortality ratio (HSMR).

The HMSR is a comparative measure of a hospital's overall mortality. It focuses on a group of diagnoses that account for 80% of all hospital deaths nationally and provides a tool for analysing hospital outcomes over time.

The results show that the overall HSMR of the trust fell from 89.6 in 2006-7 to 71.1 in 2007-8, to become the lowest among acute trusts in England.

In 2007-8, 174 fewer deaths occurred in the trust in the targeted diagnoses, and 255 fewer deaths occurred in the HMSR diagnoses compared to 2006-7. This represents a 14.5% decrease in actual deaths from 2006-7 to 2007-8.

This study demonstrates that it is possible to target care bundles across a wide range of diagnoses in a busy acute hospital trust and that this can be associated with a significant reduction in mortality in the targeted diagnostic areas, conclude the authors. These methods could also be generally applicable, they add.

Contacts:
Brian Jarman, Emeritus Professor, Imperial College, London, UK
Email b.jarman@imperial.ac.uk

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