PharmAware Blog

Have a read of this interesting guardian article about the benefits of tamiflu and relenza…

 http://www.guardian.co.uk/world/2009/may/07/tamiflu-swine-flu-drugs

The BMJ is now asking authors for data sharing statements at the end of each original research article. The statement will explain which additional data—if any—are available, to whom, and how. Those data could range from additional explanatory material to the complete dataset. People allowed access to the data might range from fellow researchers to everyone. And data might be available only on request, accessible online with a password, or openly accessible to all on the web with a link on bmj.com.

Data sharing means more than the open access publication of articles and the posting in online registries of study protocols and main results. Sharing allows other researchers—and perhaps scientists, clinicians, and patients—access to raw numbers, analyses, facts, ideas, and images that do not make it into published articles and registries. At its fullest extent, data sharing means free access for everyone. Many people would call this a moral obligation because most research is publicly funded and involves the public as participants. Other potential benefits include quicker scientific discovery and learning, better understanding of research methods and results, more transparency about the quality of research, and greater ability to confirm or refute research through replication.

For full article, go to BMJ 2009;338:b1252

Red tape is severely hampering clinical research in the UK and inadvertently “killing people”, leading researchers have warned. European legislation introduced in 2004 has led to fewer patients enrolled in clinical trials and has caused “huge delays” in research, they said. NHS bureaucracy is a further hurdle to treatments being quickly assessed, a team of UK academics added. Regulators agreed there were some problems with interpreting EU rules.

Despite increased funding in clinical trials in the UK, the number of trials being approved has stayed the same since 2004, when the European directive on clinical trials, designed to improve patient safety, came into force. Additional funding is being eaten up by paperwork, monitoring, and procedures such as detailed labelling of drugs, experts said. In 2002, 6% of trials worldwide were being done in the UK but in 2007 this was 2%.

BBC News 12/3/9

New guidance has been issued in March 2009. Have a look at http://www.abpi.org.uk/publications/pdfs/ABPI_Code_Guidance_Notes.pdf

The National Institute for Health and Clinical Excellence (NICE), the body that approves drugs for the NHS, will go head-to-head with pharmaceutical giant GlaxoSmithKline (GSK) on the issue of drug pricing at the 2009 Bupa Health Debate on 25 March. The debate pits Professor Sir Michael Rawlins, chairman of NICE against Simon Jose, senior vice president of UK pharmaceuticals at GSK, at a time when conflict between the two organisations escalates over Tyverb, a GSK breast cancer drug. NICE is refusing to approve Tyverb because it is “not a cost-effective use of NHS resources”, despite GSK’s offer to fund the drug for the first 12 weeks of treatment.

The heir to the throne has always prided himself on his alternative views, establishing himself as something of a royal iconoclast who gives voice to public fears over GM foods and nanotechnology, while pioneering a simpler vision of society based on championing organic agriculture, local produce and traditional architecture. But this time, Prince Charles’s embrace of the alternative has led to him being accused of peddling “outright quackery”.

Britain’s leading academic expert on complementary medicine has warned that the Duchy Herbals Detox Tincture - a food supplement, which combines artichoke and dandelion and promises to rid the body of toxins while aiding digestion - is based on notions which are “implausible, unproven and dangerous”.

The heir to the throne, says Edzard Ernst, professor of complementary medicine at Exeter University, is deliberately ignoring science, preferring to rely on “make-believe and superstition”.

Ernst said: “Prince Charles contributes to the ill-health of the nation by pretending we can all over-indulge, then take his tincture and be fine again. Under the banner of holistic and integrative healthcare he thus promotes a ‘quick fix’ and outright quackery.

The Guardian 11/3/9
http://www.guardian.co.uk/uk/2009/mar/11/prince-charles-detox-tincture

Medical and consumer organisations are raising concerns about plans by the European Commission to allow drug companies to provide information on prescription only drugs directly to the public. The drug industry is also questioning how the system would work in practice.

The initial reactions to measures that would allow drug companies to supply factual information on prescription only drugs to the public emerged last week at a conference in Brussels organised by the European Commission and the Organisation for Professionals in Regulatory Affairs.

The draft legislation, tabled last December, covers the type of information that may be given; the channels through which it may be supplied; the quality criteria and conditions to be met; the monitoring mechanisms to be put in place; and the sanctions to be applied in cases of non-compliance.

The conference was the first major opportunity for different groups to present their views in the same forum. The European Commission argued that citizens should have equal access to good quality non-promotional material, no matter where they live in Europe.

For the medical profession, Lisette Tiddens-Engwirda, secretary general of the Standing Committee of European Doctors, welcomed moves to empower patients but emphasised the importance of the doctor-patient relationship. “Healthcare professionals should remain the principal source of health information to patients,” she said. She also warned against a US style “horror scenario” whereby doctors and pharmacists came under pressure from the public to prescribe certain drugs.

Consumers’ organisations were even more opposed to the idea. Ilaria Passarani, the head of the health department of the European Consumers’ Association, argued that the future legislation was “based on an unworkable distinction between information and advertising.” Instead she argued for a comprehensive strategy on health information that would enable patients to choose and compare different treatments.

Paul Woods, the global compliance policy director for the drug company AstraZeneca, said that the draft legislation was close to the industry’s position and insisted that information to patients should be judged on its content and effect, not its source. He noted that nothing in the proposal went further than was already allowed in some European countries. But he questioned how prior vetting of information to the public would work in practice and called for clarification of what types of publication would be included in the proposal.

Despite the varying reactions to the proposal, the conference confirmed widespread agreement on several key principles of European practice: that the existing ban on advertising medicinal products should remain; that information should not be provided on television or radio; and that there is no desire to reproduce in Europe the freedom that drug companies have in the United States.

6/3/9, BMJ 2009;338:b894

GSK’s breast cancer drug lapatinib (Tyverb) has been turned down again in a final assessment by NICE, saying that the treatment had limited benefits and was too expensive, even after a special deal offered by GSK. Subject to appeal, NICE expects to publish final guidance on Tyverb to the National Health Service next month.

Tyverb is the first once-daily pill for breast cancer patients who over-express a protein called HER2. It is used in combination with Roche’s drug Xeloda and the two drugs together cost around 25,000 pounds a year.

5/3/9, Reuters UK
http://uk.reuters.com/article/businessNews/idUKTRE52403J20090305?rpc=401&pageNumber=1&virtualBrandChannel=0

The current role of the sales and marketing function for pharma companies will become obsolete over the next decade as the industry shifts from mass marketing to target marketing, according to a new report by PricewaterhouseCoopers (PwC).

The report, Pharma 2020: Marketing the Future, states that current giant pharmaceutical sales forces will be replaced by a smaller, smarter and more effective sales force model, requiring pharma companies to recruit and train people with new skills who can negotiate with increasingly powerful healthcare payers and pharmacoeconomic assessment agencies.

In addition, the report states that pharmaceutical companies will adopt new talent management strategies, as well as ensure that performance measures and incentive systems are aligned with the behavior that will be needed to operate effectively in a more integrated environment.

Joe Palo, an advisor to PwC Pharmaceutical and Life Sciences Advisory Practice, told MM&M that as the industry moves toward specialty products and away from primary care, fewer sales force personnel will be needed. “It’s not going to go to zero, you are going to have blockbuster products and sales forces going into primary care, but there will be less.”

In addition, pharma companies will likely recruit sales force personnel who have more of a clinical background such as pharmacists and nurses.

PwC’s Palo said that while the industry has always welcomed people who had clinical skills such PharmDs and RNs, that percentage will rise primarily because of the nature of the specialty products which are going to require a deeper understanding of pathology and alternative therapies. “It will be very helpful and candidates will distinguish themselves by being able to have a healthcare perspective. Having a nursing or PharmD degree would be good, but having been a practicing PharmD or a practicing nurse for a few years in a healthcare system would be even better,” said Palo.

The report claims that the current sales and marketing model is becoming increasingly ineffective, and although US sales calls to physicians still accounts for more than half the market share new brands win during their first year of life, one in five doctors now refuses to see any sales representatives and returns on sales visits to doctors have declined.

According to the report, many of the industry’s biggest markets are saturated with sales representatives and the number of pharmaceutical sales professionals has been growing three times faster than the number of physicians.

Between 1996 and 2005, the number of US sales representatives nearly doubled to 100,000 while the number of practicing physicians rose by just 26%. Between 2004 and 2005, there was a 23% drop in dollar growth per sales call in the US. Pharmaceutical manufacturers have responded with various cost-cutting measures so that by the end of 2008, Big Pharma had announced plans to shed over 60,000 jobs globally, many of them in sales and marketing, the report concluded.

According to the report, many pharmaceutical companies are shifting their product mix and investing in genomics, proteomics and metabolomics for specialized therapies. As their focus switches to specialist medicines, the pharmaceutical markets and sales function will be organized around brands, not products. The potential for creating brands that physicians and patients value is much greater with packages comprising different product-service combos than it is with isolated products, the report concludes.

Medical Marketing and Media, 25/2/9
http://www.mmm-online.com/Pharma-sales-forces-will-shrink-clinical-skills-in-demand/article/127857/

Roche was on Friday rebuked by British regulators for offering £10 ($14) gift vouchers to children to persuade them to take one of its medicines. The Prescriptions Medicines Code of Practice Authority ruled Roche had “brought discredit” on the industry for a serious breach of its ethical rules of conduct.Between 2004 and 2007, the company gave gift vouchers for use in Toys R Us, Tesco and Boots to children and teenagers prescribed Pulmozyme, its inhaled medicine to prevent lung infections for patients with cystic fibrosis. For a year after Roche decided to stop the voucher scheme in September 2007, it failed to recognise that the agency contracted to run the voucher scheme was still operating it, and to end it.
Financial Times

http://www.ft.com/cms/s/0/9ac2a3c4-0523-11de-8166-000077b07658.html?nclick_check=1