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1) Agencia Européia de Medicamentos (EMA) acusada de proteger os lucros do setor farmacêutico em detrimento dos pacientes
Pesquisadores da área médica exigem acesso completo a relatórios com dados de ensaios clínicos de medicamentos, estejam eles publicados ou inéditos, para que os benefícios e malefícios do tratamento possam ser avaliados de modo independente pela comunidade médica. Em artigos publicados na Revista Médica Britânica (BMJ), os pesquisadores denunciam que essas informações são disponibilizadas de forma seletiva e que isso pode ter conseqüências desastrosas. Como exemplo é citado o analgésico Vioxx (rofecoxib), da Merck, que foi retirado do mercado e pode ter causado cerca de 100 mil ataques cardíacos. Os autores do artigo dizem que travaram uma batalha de 3 anos junto à Agência Européia de Medicamentos para ter acesso aos relatórios dos ensaios de dois medicamentos anti-obesidade que foram retirados do mercado por apresentarem riscos com distúrbios psiquiátricos. A Agência recusou acesso aos dados alegando que isso afetaria interesses comerciais e que não havia interesse publico em relação a divulgação dessas informações. “Tem algo fundamentalmente errado nas nossas prioridades do nosso sistema de saúde se o sucesso comercial depende da ocultação de dados importantes para decisões racionais tomadas por médicos e pacientes”
2) Sanofi coloca sua fé nos mercados emergentes
Executivo da empresa farmacêutica francesa Sanofi-Aventis declara que mercados emergentes vão desempenhar um papel central nas vendas, compensando a perda de mercado no EUA e Europa, decorrente da entrada de genéricos. Atualmente, um terço das vendas da empresa já são feitas em mercados emergentes, o que já representa um volume maior do que as vendas nos EUA e na Europa.
3) Análise: Big Pharma desnuda o motor defeituoso de P&D
A indústria farmacêutica, que movimenta anualmente 850 bilhões de dólares, enfrenta a maior onda de expiração de patentes da historia e quase não dispõe de novos medicamentos para substituir aqueles que enfrentam concorrência de genéricos. A desvalorização do setor tem ligação com os atrasos Em encontro organizado pela Reuters, líderes da indústria concordam que os gastos da industria com P&D precisam ser repensados, pois o atraso nos ganhos para investimentos feitos nesta área tem sido um fator crucial para a desvalorização do setor. Os gastos com P&D, que foram ampliados nos últimos anos, agora começam a cair. A Pfizer, anunciou corte de um quarto do seu orçamento de P&D para os próximos dois anos, já a GlaxoSmithKline reduziu em 28% o número de profissionais trabalhando em P&D.
1) EMA accused of putting pharma profits before patients
Pharma Times – 11/05/2011
Regulators are "protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data", according to researchers in articles published by the BMJ.
They call for full access to full trial reports, both published and unpublished, "to allow the true benefits and harms of treatments to be independently assessed by the scientific community." Peter Gotzsche and Dr Anders Jorgensen from the Nordic Cochrane Centre in Denmark write that despite the existence of hundreds of thousands of clinical trials, "doctors are unable to choose the best treatments because research results are being reported ively".
They claim that ive reporting can have "disastrous consequences". For example, they say Merck & Co’s now-withdrawn painer Vioxx (rofecoxib) has "probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s".
Three-year ‘struggle’ to get unpublished data
The authors go on to what they call a three-year struggle to access unpublished trial reports for two anti-obesity drugs, Sanofi-Aventis now-withdrawn Acomplia (rimonabant) and Roche’s Xenical (orlistat), submitted by the manufacturers to the European Medicines Agency.
This information "was important for patients because anti-obesity pills are controversial,” they say, and "people have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been de-registered for safety reasons".
However, Prof Gotzsche and Dr Jorgensen claim the EMA refused access, arguing that this would undermine "commercial interests and that there was no overriding public interest in disclosure". They also cited the "administrative burden involved and the worthlessness of the data after they had edited them". The authors appealed to the European ombudsman, who criticised the EMA’s refusal to grant access. But only after the ombudsman accused the agency of maladministration did the regulator agree to widen public access to documents.
‘Fundamentally wrong’
“There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients,” say Prof Gotzsche and Dr Jorgensen. They call on other drug regulatory agencies to follow suit and suggest that access should be prompt and that documents should be provided in a useful format to allow for independent scrutiny.
“Drug agencies should get rid of the huge paper mountains and require electronic submissions from the drug companies, including the raw data, which should also be made publicly available,” they conclude.
In an accompanying editorial, researcher Andrew Vickers of the Memorial Sloan-Kettering Cancer Center, New York says "the system is broken and needs fixing". He s a new initiative by the Wellcome Trust to tackle the problem by developing principles for funders with regard to data sharing, and suggests that the medical research community “get used to it.”
He argues that once medical researchers start publishing their data, and depositing it in data archives, "they will discover not only that it is painless, but that it affords huge advantages to medical science, and to patients present and future." The BMJ added that it believes "systematic efforts are needed to assess this largely unexamined threat to the integrity of evidence-based medicine".
2) Sanofi places its faith in emerging markets
Pharma Times – 11/05/2011
Sanofi’s chief executive is confident that emerging markets will play a major part in offsetting sales lost to generics in the USA and Europe but the road to increased profitability may still be rough.
The French drugmaker already derives a third of its sales from emerging markets, selling more there than in the USA or Europe, and speaking at the Reuters Health Summit, Chris Viehbacher said the company has a competitive advantage, having had a presence in many of those markets for more than 50 years.
He told the news agency that Sanofi has "a range of tail products and production networks that six or seven years ago would have been seen as non-strategic by most pharma companies". However, they have "now turned out to be hot properties because if you can produce locally you can achieve the same level of margins on an operating level as we do in Europe".
Mr Viehbacher went on to say that "I was astounded to find that in emerging markets our margins are sometimes higher than in Germany or France." He claimed these areas "are on a growth track…it’s not going to be all smooth, but over the next five to 10 years they will become a bigger growth driver."
The company’s administrative network also gives it an advantage, Mr Viehbacher said, which is important "from the point of view of depth of management, distribution, government affairs". Over the past two years the company added 10,000 people to its emerging markets business, bringing the total to 40,000.
He told Reuters that "you sit in Shanghai and see 1 billion in China, another billion in India and another billion in other parts of Asia. The numbers are mind-boggling."He concluded by noting that Sanofi will make more acquisitions in emerging markets, but "the price of assets is clearly going up. We’ve been able to find some assets but you really have to hunt."
3) Analysis: Big Pharma strips down broken R&D engine
Reuters – 11/05/2011
Even as drugmakers cut research and development (R&D) budgets, there are tentative signs that the flow of new medicines is improving, potentially pointing to a long-awaited improvement in research productivity.
The $850-billion-a-year industry still doesn’t have nearly enough new drugs to replace all those facing generic competition in the biggest wave of patent expirations in history.
But by adopting a far tougher approach to R&D spending in future, pharmaceutical executives believe they can fix lagging returns in R&D arguably the biggest single factor behind the declining valuations of the sector over the past decade.
Pfizer (PFE.N), the world’s biggest drugmaker, has taken the most dramatic steps under new Chief Executive Ian Read, with plans to slash around a quarter of its R&D budget over the next two years as its labs focus only on the most lucrative areas. It is not alone, however.
Industry leaders speaking at the Reuters Health Summit in New York this week agreed that industry-wide spending on R&D after years of strong increases is set to fall, although the pattern will vary from company to company.
"When we get the final numbers for 2010 over 2009 globally, I think we are going to see it is in decline," said AstraZeneca (AZN.L) Chief Executive David Brennan.
Chris Viehbacher, his counterpart at Sanofi (SASY.PA), sees the pace of cuts picking up this year and next, as the sector enters the heaviest period of generic erosion.
A number of huge products, like Pfizer’s $11-billion-a-year cholesterol fighter Lipitor and Sanofi and Bristol-Myers Squibb’s (BMY.N) blood thinner Plavix, go off patent in 2011 and 2012.
"Five years ago people would say ‘the more I spend on R&D, the more shots in goal I will have, the more successful I will be,’" Viehbacher said.
"Now you have got some investors out there who believe that what we do in R&D is actually value destroying," he added.
Certainly, the glory days are over. Last year, the U.S. Food and Drug Administration’s drugs division approved just 21 novel medicines less than half the level seen in 1996 and 1997.
Yet Dr. Janet Woodcock, head of the FDA’s drugs center, said the agency had already approved 12 so far this year, partly thanks to the increasing number of smaller biotech companies coming forward with successful products.
"The nadir has been reached and we’re coming up the other side," Woodcock said.
BETTER MOUSETRAP
Investors will take some convincing, not least because the 13-year cycle for winning approval for a new drug makes it tricky to nail down just how much bang companies are getting for their R&D buck. And biting the bullet is not always easy."Every CEO believes they have a better mousetrap than everybody else, which sometimes gets in the way of making rational decisions," said Novo Nordisk (NOVOb.CO) CEO Lars Sorensen.
GlaxoSmithKline (GSK.L) is one company that has taken a stab at doing the math. It currently reckons its rate of return is around 11 percent and has set a goal of increasing this to 14 percent, an increase of 25 percent, over the medium term.
GSK has already cut back on research, with the number of staff working in R&D down 28 percent since 2006. It may go down more but further cuts will be constrained by the need to pay for a bunch of large late-stage clinical trials.
"Overall, we continue to push for getting better at what we spend, and hopefully that can lead to further reductions. But I think we do have a big pipeline to pull through, and that’s going to limit our ability to be totally flexible," said Chief Financial Officer Simon Dingemans. Not all drugmakers agree with the approach of Pfizer’s Read, who cheered his investors in February by matching deep cuts in R&D with a $5 billion increase in the group’s share buyback program.
Arch-rival Merck & Co (MRK.N) opted to withdraw its long-term profit forecast rather than take a hatchet to its research budget. Some biotech companies, meanwhile, are basking in the success of recent products at a time when Big Pharma has been floundering and will be spending more. Celgene (CELG.O) CEO Robert Hugin said he expected record R&D spending in 2011.