Roche’s secrecy over Tamiflu condemned

by JoelLane 1. November 2012 12:25

Tamiflu (resized) Roche has been urged by the British Medical Journal to keep its promise and release the trial data on Tamiflu (oseltamivir).

The antiviral was widely prescribed across Europe during the ‘swine flu’ crisis, but its efficacy and safety have been questioned.

Roche, who promised three years ago to publish the trial data, are accused of stepping “outside the circle of responsible pharmaceutical companies”.

Dr Fiona Godlee, BMJ Editor-in-Chief, wrote in an open letter to Professor Sir John Bell, Roche’s Company Director: “Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny.”

The European Medicines Agency has started infringement proceedings against Roche, alleging that it failed to make available 80,000 reports on adverse reactions to Tamiflu.

Dr Godlee and 27 other doctors have also written an open letter to The Times urging UK pharmaceutical companies to release all clinical trial data on drugs that are currently in use.

Health Minister Norman Lamb has agreed to meet experts and discuss the issue of clinical trial transparency.

According to an investigation headed by members of the Cochrane Commission, there is no compelling evidence that Tamiflu prevents pneumonia or other complications of influenza.

According to the Cochrane team, 60% of the patient data from Roche’s 123 Phase III trials of Tamiflu have still not been released. They accuse Roche of “the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects.”

In her letter to Professor Bell, Dr Godlee said: “In refusing to release these data of enormous public interest, you put Roche outside the circle of responsible pharmaceutical companies.”

DH plans immunisation programmes

by IainBate 30. July 2012 12:54

DH plans immunisation programmes - Pharmaceutical Field The Department of Health is drawing up plans to immunise teenagers and pregnant women against whooping cough after the biggest outbreak of the disease in two decades.

Almost 2,500 cases have been reported in the first six months of this year resulting in the death of five babies.

Dr Mary Ramsey, head of immunisation, Health Protection Agency (HPA), said they were “working closely” with the DH’s Joint Committee of Vaccination and Immunization (JCVI) to tackle the “ongoing outbreak”.

Whooping cough, which may be fatal in young babies, can lead to pneumonia and bronchiectasis.

Meanwhile, pensioners may also be immunised with a shingles jab under revised Government plans.

Health Ministers first announced a vaccination programme in January 2010 but have faced supply issues after pharmaceutical companies struggled with manufacturing difficulties and overseas demand.

However, revised plans to give more than 4.5 million pensioners the jab from next year have now been confirmed by the Department of Health following advice from the JCVI.

A spokesperson from the DH said they were “disappointed” enough vaccines were not currently available to introduce the immunisation programme sooner.

New coalition supports immunisation in EU

by JoelLane 24. January 2012 13:32

Pf industry news A coalition of European public health experts, clinicians and industry representatives has formed to promote vaccination strategies in Europe.

SAATI (Supporting Active Ageing Through Immunisation), whose partners include Pfizer, has formed to take action during 2012, the EU’s Year for Active Ageing and Solidarity between Generations.

The coalition aims to raise public awareness of the value of preventative vaccination in an age-based health approach, leading to a more consistent and widespread use of immunisation.

At an inaugural meeting funded by Pfizer, the SAATI partners developed a consensus statement on the barriers to effective immunisation programmes for adults in Europe. The statement called for more effective public health communication on the value of vaccines and the need for age-based national health policies.

Vaccination is effective in preventing major infectious diseases such as influenza, pneumonia, diphtheria and tetanus. The consensus statement noted that the “most crucial age” for vaccination is the fifties, before the immune system starts to decline.

SAATI’s partners include Sylvie St-Laurent, Senior Director, International Public Affairs, Pfizer PIO, as well as representatives of the International Longevity Centre (UK), the European Men’s Health Forum, the European Institute of Women's Health and a number of major hospitals and academic medical centres.

“We are taking advantage of the EU’s focus on Active Ageing to underline the need to review European policies, practices and communication around adult vaccination,” said Professor Javier Garau, Chair of SAATI.

“Unlike with infants, there are no comprehensive or consistent guidelines for adult immunisation, and we believe this is one of the major barriers to reducing preventable and sometimes fatal illnesses.”

Sally Greengross, Chief Executive of the International Longevity Centre, commented: “Immunisation is not just for children, but is essential across the life course. We need to normalise immunisation as an important part of healthy ageing. Comprehensive adult vaccination strategies would significantly reduce the incidence and burden to individuals, employers and healthcare systems.”

Pfizer and GSK boost global war on pneumonia

by JoelLane 19. December 2011 11:57

Pf industry news Pharmaceutical giants Pfizer and GlaxoSmithKline (GSK) have both agreed to increase and extend their supply of discounted pneumonia vaccine to developing countries.

Pfizer will supply an additional 180 million doses per year of its vaccine Prevnar 13 at the discounted price of $3.50 per dose, and GSK will match that with its vaccine Synflorix.

The companies’ new agreements build on an existing 10-year plan to supply the Global Alliance for Vaccines and Immunisation (GAVI), an international partnership funded by several developed nations with the Bill and Melinda Gates Foundation.

Based in Geneva, GAVI aims to make immunisation programmes available throughout the developing world.

In March 2010, Pfizer and GSK agreed independently to supply GAVI with 300 million doses of pneumonia vaccine over a decade. Under the new agreement, both companies will supply an additional 180 million vaccines each year to 2023.

Pneumonia and related diseases account for one in every four child deaths in developing countries. According to GAVI, affordable vaccines could save up to 7 million lives by 2030.

“Pfizer is proud to broaden and extend access to our vaccine to advance public health,” said Mark Swindell, President of Pfizer’s vaccine division.

The vaccines market in poorer countries is currently a major area of investment for pharmaceutical companies, as nations with limited health budgets are focusing on the prevention of lethal diseases.

Astellas pneumonia drug approved in EU

by emma 16. September 2011 15:53

Pf product news

Astellas has received EU approval for Vibativ, an injectable antibacterial drug to treat pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA).

This rare approval for a new antibiotic answers the pressing need for drugs to treat resistant bacterial infections.

Rick E Winningham, CEO of US company Theravance, original owner of the rights of Vibativ, said: “We believe that Vibativ will become an important medicine addressing the urgent medical need for new antibiotics to treat Gram-positive infections caused by MRSA”.

The telavancin drug is indicated for the treatment of adults with hospital-acquired pneumonia, including ventilator-associated pneumonia.

The FDA previously approved Vibativ in the US for the treatment of complicated skin and skin structure infections (cSSI) caused by MRSA in 2009, but asked for more data before clearing its use to treat hospital-acquired pneumonia.

In a statement, Astellas said that plans to launch in Europe were “under review.”

Study proves benefits of Tamiflu

by diana 29. September 2010 16:41

Tamiflu (resized) Tamiflu (oseltamivir) may have protected patients from developing pneumonia during the 2009 swine flu pandemic, a study of cases in China has demonstrated.

The research, published on bmj.com, shows that treatment with Tamiflu was also associated with a shorter duration of fever and viral RNA shedding.

Researchers reviewed the medical records of 1,291 patients in China with laboratory confirmed mild H1N1 infection during the 2009 pandemic. Three quarters (76%) were treated with Tamiflu from a median of the third day of symptoms.

Out of the 920 patients who had a chest x-ray, a minority (12%) had abnormal findings consistent with pneumonia and Tamiflu was identified as a significant protective factor.

However, the authors stress that these findings should be interpreted with caution, due to “the retrospective design of this work and the fact that not all patients underwent a chest x-ray”.

They call for continued investigation into the effectiveness of antiviral treatment “to allow for improvement both in clinical treatment and public health guidance”.

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