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Press releases Saturday 20 January 2007

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Lessons from Vioxx case: new approach needed to restore faith in pharmaceutical industry
Referral management schemes damage patients± interests
Informing partners can help cut sexually transmitted infections
Lifestyle changes effective in protecting against Type II diabetes
Sanitation is greatest medical milestone since 1840

(1) Lessons from Vioxx case
(New approach needed to restore faith in pharmaceutical industry)
http://www.bmj.com/cgi/content/full/334/7585/120

The pharmaceutical industry, academia and government agencies need to work together to restore faith in drug development, say doctors in this weeks± BMJ.

They argue that the recent litigation over the drug Vioxx, produced by Merck and Co. Inc., has highlighted the failings of the current system, which can be open to abuse.

Vioxx (rofecoxib) was introduced in 1999 as an effective, safer alternative to non-steroidal anti-inflammatory drugs (NSAIDS) for the treatment of pain associated with osteoarthritis. It was subsequently found that the drug increased the risk of cardiovascular disease (CV) and withdrawn from the worldwide market. Merck now faces legal claims from nearly 30,000 people taking Vioxx who experienced a CV event while taking the drug.

In the course of the litigation and in dealings with medical journals it was revealed that Merck had obscured critical data on the drug±s toxicity, given a biased presentation of Vioxx research and had used ghost writers to author papers on Vioxx ± which were published in a number of academic journals.

The authors argue that the Vioxx case is ±bad news for industry, academics, journals and the public± but conclude that ±its [Merck's] behaviour may not be any different from that of others in the pharmaceutical or biotechnology industry.±

They say that academic medicine, industry, medical journals and government agencies must come together to define a set of principles governing drug development. They also call for new approaches to collaboration and development of drugs, including storing research data on independent academic sites ± rather than with the pharmaceutical company, stricter scrutiny for research which has potentially immense financial implications and penalties for ghost-writing.

They conclude that ±collaborations between academics, practicing physicians, industry and journals are essential in advancing knowledge and improving the care of patients. Trust is a necessary element of this partnership, but the recent events have made it necessary to institute proper systems that protect the interests of patients.±

Contact:
Dr Harlan Krumholz, Yale University School of Medicine, Connecticut, USA
Email: Harlan.krumholz@yale.edu

(2) Referral management schemes damage patients± interests
http://www.bmj.com/cgi/content/full/334/7585/156

Referral management schemes pose a serious threat to patients± interests, argues Peter Lapsley, Chief Executive of the Skin Care Campaign, in this week±s BMJ.

Referral management schemes are springing up across the NHS as a means of reducing primary care trusts± spending on secondary care services.

The justification given for the introduction of the schemes is that they bring services ±closer to home± ± a mantra repeated often by the government at present. But trust managers admit privately that the true purpose of the schemes is to reduce costs in the face of the budget deficits so many of them are confronting, he says.

Typically, such schemes require that 80% of GPs± referral letters be reviewed in primary care and that 60% of cases should be retained within the trust. In many cases GPs are being offered financial incentives to participate in the schemes.

Lapsley firmly believes that these schemes pose a serious threat to patients± interests. They introduce an extra step in the patient±s journey, delaying the diagnosis and treatment of often complex and difficult diseases, he writes.

What is more alarming is that some primary care trusts now deliberately delay outpatient appointments, refusing to fund routine paper referrals seen within eight weeks of the date of the referral letter. In contrast, patients who can be booked into clinics directly through the Choose and Book electronic booking service can be seen within two to three weeks, no matter what their complaint.

The schemes also remove any vestige of ±patient choice,± another government mantra, he adds.

In the case of dermatology, about 15% of GPs± consultations in Britain relate to skin disorders, yet the average undergraduate curriculum has only six days of dermatology, and only 20% of GP vocational training schemes include a dermatological component. Practice nurses receive no such training.

Referral management schemes therefore create a real risk that patients with skin diseases will be seen by clinicians who lack the necessary training and experience, greatly reducing the likelihood of prompt and accurate diagnosis, not least in respect of skin cancer, he argues.

The schemes are also insulting to GPs, second guessing their decisions. They undermine the viability of secondary care dermatology, and they remove any incentive for secondary care specialists to support or develop the role of the GP with a special interest in dermatology.

The schemes may provide a short term solution to a short term financial problem. The risk, though, is that they will do lasting damage, he concludes.

Contact:
Peter Lapsley, Chief Executive, Skin Care Campaign, Highgate, London, UK
Email: plapsley@eczema.org

(3) Informing partners can help cut sexually transmitted infections
(Improved effectiveness of partner notification for patients with sexually transmitted infections: systematic review)
http://www.bmj.com/onlinefirst_date.dtl

Doctors should encourage patients with sexually transmitted infections to tell their partners to seek treatment and, in some cases, provide home testing kits or drugs to help reduce infection rates, says a new study on bmj.com.

Partner notification is an important part of managing most curable sexually transmitted infections, but the stigma attached to sexually transmitted infections often makes this difficult.

Researchers analysed 14 studies involving 12,389 women and men diagnosed with a common sexually transmitted infection, including chlamydia, gonorrhoea, and non-specific urethritis.

Three new strategies were used in these studies that made it easier for patients to share responsibility for the care of their sexual partners: patient delivered partner therapy (where a patient is given drugs or a prescription for their partners), home sampling for partners, and providing additional information for partners.

All three strategies were more effective than simple patient referral (where a patient is simply encouraged to tell their partners to seek treatment).

However, the team found that simple patient referral, with extra information about the infection and its treatment that the patient can give to their partners, seemed to be as effective as patient delivered partner therapy.

Involving patients with sexually transmitted infections in shared responsibility for the care of their sexual partners improves outcomes, say the authors. Health professionals should consider these three strategies for the management of individual patients.

Contact:
Nicola Low, Reader in Epidemiology and Public Health, Department of Social and Preventive Medicine, University of Berne, Switzerland
Email: low@ispm.unibe.ch

(4) Lifestyle changes effective in protecting against Type II diabetes
(Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes mellitus in individuals with impaired glucose)
http://www.bmj.com/onlinefirst_date.dtl

Changing to a healthier lifestyle appears to be at least as effective as taking prescription drugs in reducing the risk of developing Type 2 diabetes, says a new BMJ study.

Type 2 diabetes is a growing problem ± in England around 1.3 million people have diabetes and around 5% of total NHS resources are used for the care of people with diabetes.

Researchers from Leicester reviewed studies which measured the effects of different interventions ± lifestyle, diabetes drug and anti-obesity drug ± on people with impaired glucose tolerance (1).

They found that lifestyle changes, e.g. switching to a healthier diet and increasing exercise to be at least as effective as taking prescription drugs. On average, lifestyle changes helped to reduce the risk of developing type 2 diabetes by around half. Lifestyle changes were also less likely to have adverse side-effects.

However, the researchers say that both lifestyle changes and prescription drug taking must be sustained in order to prevent the development of Type 2 diabetes.

The authors say that as global rates of Type 2 diabetes are likely to double by 2030, interventions to prevent the condition will have an important role to play in future health policies. The study findings have large implications for public health policy, however, the authors note that if lifestyle changes are to be truly effective more needs to be done to support people to adopt healthier lifestyles.

(1) People with impaired glucose tolerance have a high risk of developing type II diabetes

Contacts:
Keith Abrams,, Professor of Medical Statistics, Centre for Biostatistics and Genetic Epidemiology, Department of Health Sciences, University of Leicester, UK
Email: keith.abrams@le.ac.uk

Kamlesh Khunti Clinical Senior Lecturer, Division of General Practice and Primary Health Care, Department of Health Sciences, University of Leicester, UK
Email: kk22@le.ac.uk

(5) Sanitation is greatest medical milestone since 1840

Sanitation has been voted the greatest medical milestone since 1840, said the BMJ today.

Over the last 10 days, more than 11,000 people from around the world have voted in the BMJ±s poll to find the greatest medical breakthrough since the journal began.

The project is a celebration of the most important medical advances of the past 166 years to mark a complete redesign of the journal and its website.

Sanitation beat 15 other medical advances, including the discovery of antibiotics, the creation of the Pill, and the development of vaccines.

Despite the strong field, sanitation was the undisputed winner with 1,795 votes. Antibiotics was a close second with 1,642 votes and anaesthesia took third place.

Leading doctors and scientists championed each milestone. Speaking after the results were announced, Professor Johan Mackenbach of Erasmus University Medical Center, Rotterdam, the Netherlands, who championed sanitation, said: "I±m delighted that sanitation is recognised by so many people as such an important milestone. The general lesson which still holds is that passive protection against health hazards is often the best way to improve population health.

The original champions of the sanitary revolution were John Snow, who showed that cholera was spread by water, and Edwin Chadwick, who came up with the idea of sewage disposal and piping water into homes.

Inadequate sanitation is still a major problem in the developing world. In 2001, unsafe water, sanitation and hygiene accounted for over 1.5 million deaths from diarrhoeal disease in low and middle-income countries. Clearly, sanitation still plays a vital role in improving public health now and in the future."

Dr Fiona Godlee, BMJ Editor said: "The response to our poll has been overwhelming, it is deeply heartening to see science and medicine provoke such passion and debate. Selecting just one winner was always going to be difficult, but I±m delighted that the BMJ has helped to remind everyone of the great contribution that medicine and science has made to our lives now and in the future."

Notes to Editors:

The total number of votes received was 11 341.

Contacts:
The BMA Press Office (pressoffice@bma.org.uk) is available for for further details on the poll results.
Professor Johan Mackenbach is available for media interviews. Please contact him directly at j.mackenbach@erasmusmc.nl

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