Ex Big da Big Big Pharma desagrava epidemiologistas. E, agora speakers?

Imperdível a reportagem no The IN VIVO Blog sobre a saída de JP Garnier da Glaxo Smith Kline. Os pontos apresentados por ele decorrentes de vários problemas, mas principalmente do Avandia mostram o quanto a Big Pharma errou. Epidemiologistas estamos sendo desagravados pelo CEO da maior Big Pharma do ataque constante dos speakers da própria Big Pharma.

Há décadas que se critica o abuso dos "surrogate end-points". Leiam abaixo a opinião de Garnier sobre o uso da hemoglobina glicada como desfecho em oposição a um evento clínico como gangrena ou infarto do miocárdio. (clique aqui para ler a reportagem completa)

Expect to do more outcomes studies.“There will be more demands for outcome studies. People are even questioning whether hemoglobin A1c is a good indicator for diabetes. It is very easy to say well why don’t you do outcome studies and show us that over five or six years you can reduce the rate of gangrene and heart attacks and the like. Well, if we have to do that, it is going to be a long time before the product can hit the market. So we’re going to have to deal with this issue.”Once again, it is not just Avandia that supports that argument. Look at ENHANCE.

Avandia: the Empire strikes back

The Wall Street Journal (ver parte do texto abaixo) mostra o contra-ataque da Glaxo Smith Kline e a situação aflitiva dos propagantistas farmacêuticos. O interessante não é bem o risco causado aos pacientes, mas a queda das ações da empresa. Em negrito, as mudanças da bula que na Europa já indicava risco de infarto do miocárdio.
Glaxo Courts Doctor Support of Avandia
Similar Consumer Ads Aren't Yet Planned But Won't Be Ruled Out
By JEANNE WHALEN and ANNA MATHEWS May 25, 2007 GlaxoSmithKline PLC, under pressure to protect its diabetes drug Avandia, is reaching out to physicians to defend the drug's safety but isn't currently planning a similar ad campaign for consumers.In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman. (…..)
Dr. Nissen's analysis led to a sharp drop in Glaxo's stock price, and some analysts have predicted Avandia sales could be cut in half because of physician and consumer concerns. The Glaxo spokeswoman said the company isn't planning consumer ads defending Avandia but won't rule them out, either. "At the moment, there is an information vacuum, and GSK may need to step into the void," she said. (…….)
When Avandia was approved, its label held a mild precaution noting that in animal studies, there had been signs of plasma volume expansion and heart hypertrophy, signals of a heart-failure risk. It also noted that while LDL, or "bad cholesterol," went up in Avandia patients, HDL, or "good cholesterol," ended up rising, as well. Later, the drug's label got a new warning that Avandia, like similar treatments, might exacerbate or lead to heart failure. The warning also noted that when taken with insulin, such drugs may "increase the risk of other cardiovascular adverse events." Last year, the Avandia label warning got beefed up a bit, saying patients with heart failure who took Avandia had a higher risk of cardiovascular events. The Glaxo analysis showing potential heart-attack risk hasn't been placed in the U.S. label, although it is mentioned in the European label. On Internet sites popular with drug-industry sales representatives, people claiming to work for Glaxo have been posting hundreds of messages this week bemoaning the difficult position Dr. Nissen's study has put them in.

Avandia: leia The Wall Street Journal e vote no prêmio Zeca Pagodinho quesito diabetes.

A melhor cobertura sobre o tema encontra-se em jornal especializado em economia pelo motivo simples: a queda nas ações da Glaxo Smith Kline.

O tema Avandia já foi tratado aqui em 16.9.06 analisando o estudo básico para o Avandia. "Dream: o óbvio é comprovado para o diabetes". Nas próximas semanas, médicos que não têm a mínima idéia como organizar uma meta-análise, mas sabem muito bem como agradar uma empresa farmacêutica estarão dando entrevistas, fazendo palestras e outras coisas sobre a "segurança da Avandia". Aguardem a saraivada de intrigas contra Steven Nissen. Uma no blogue do WSJ diz que ele será o commissioner da FDA em um provável governo Hillary Clinton.

Aqui, no Brasil vamos ver quem vencerá o prêmio "Zeca Pagodinho" no quesito diabetes.

Big Pharma não é pejorativo, mas setor muito poderoso.

Carlos Alberto Sardenberg (Estadão, 14/05/07) discutindo a questão da indústria farmacêutica faz uma primeira afirmativa incorreta: o termo Big Pharma. Ele não é pejorativo, utilizado pelo Financial Times, defensor extremado da iniciativa privada. A indústria farmacêutica merece ser avaliada pela importância estratégica e pelo mercado cativo que consegue em países com prática médica estatizadas.

Sardenberg faz várias afirmativas como inflacionar os tradicionais 800 milhões de dólares para um novo medicamento para um bilhão. Outra afirmativa está foral de local: o custo de marketing no Brasil é muito maior do que o destinado a pesquisa e desenvolvimento.

A grande questão nossa aqui foi que ao introduzir genéricos e, principlamente ao aceitar patentes, não houve exigência de nenhuma contrapartida. Exemplo: deveriámos cobrar 50 centavos de cada medicamento genérico para um fundo de pesquisa e, ao mesmo tempo exigir da Big Pharma a constituição de plantas industriais e tecnológicas no páis. Nada disso foi feito e, hoje estamos sem estrutura de financiamento na área farmacêutica o que está nos levando a um beco sem saída. Afinal, não temos como exigir investimento de quem estamos garantindo patente e, por outro lado, o custo das empresas indianas e chinesas em genéricos inibe a indústria nacional.

Outra questão nossa é viver sempre nos extremos ideológicos de adoração a repúdio ao empreendedorismo e lucro. Sou partidário que é perfeitamente possível conviver com divergências sérias - como a atual com efavirenz - desde que cada setor faça a sua parte. No lado brasileiro, valorizar as suas próprias instituições como agências reguladoras e universidades para que cumpram seu papel de controlar e educar, respectivamente. Atividades que a Big Pharma adora se imiscuir, tal como o jogador que quer apitar o jogo.

Tratamento da aids: Abbott se acerta com a Tailândia.

The Wall Street Journal noticia acerto entre a Abbott e o governo da Tailândia nos preço do Kaletra, para tratamento da aids. Tudo isso depois da represália da empresa em registrar e vender nos medicamentos àquele país, por causa da possibilidade de entrada de genéricos para aids. O novo preço é inferior ao dos genéricos. Abaixo, trecho da matéria, onde destaco em negrito que os países emergentes são fundamentais para manter a lucratividade da Big Pharma, cujas vendas estão em queda nas economias centrais.

Abbott's Thai Pact May Augur Pricing Shift
By NICHOLAS ZAMISKA in Hong Kong and JAMES HOOKWAY in BangkokApril 23, 2007
Abbott Laboratories has backed away from a confrontation with the Thai government over patent protection for a popular AIDS treatment, a concession that could embolden other developing countries pushing big drug makers to lower the price of their products.
Abbott is offering to sell the latest version of its AIDS drug Kaletra in Thailand at a discounted rate, according to Miles D. White, Abbott's chief executive. The move reverses Abbott's decision in February to withhold the new form of Kaletra, called Aluvia in some countries, from Thailand following a Thai government announcement it would allow sales of generic versions of the drug and other branded medicines to cut patients' costs. "In this particular case, in the name of access for patients, we offered to resubmit Aluvia at our new price, which is lower than any generic, provided they wouldn't issue a compulsory license," Mr. White said. He said the initial decision was driven by "concern that compulsory licensing would be abused ever-more widely, using HIV as an excuse." Jennifer Smoter, a spokeswoman for Abbott, said Thailand's health ministry has expressed interest in the offer, but a resolution hasn't been reached. Abbott's move doesn't affect its decision to withhold six other drugs from Thailand. Abbott Laboratories in February withheld an AIDS drug from sale in Thailand after the government said it would allow sale of generic versions of drugs. • What's New: Backing down, Abbott is offering to sell the drug in Thailand at a discounted rate. • The Significance: Other developing nations may push for lower drug prices.
• The Background:Abbott's turnabout could crimp growth of global drug makers, which rely on emerging markets to compensate for slowing growth in home markets. Gustav Ando, an analyst for Global Insight, an economic-forecasting firm in Waltham, Mass., said, "If one country does it...any country can do it.... It's not going to stop there." Abbott, of Abbott Park, Ill., in February, refused to sell the country seven of its newest drugs. The move appeared to backfire, prompting consumer boycotts in Thailand, bringing human-rights advocates out in support of Thailand's policy and provoking protests from some Abbott shareholders, who argued Abbott should sell its latest drugs in Thailand. Thailand generated about $30 million a year in sales for Abbott, said a person familiar with the company's sales.
In backing down, Abbott is joining Merck & Co. and Sanofi-Aventis SA, which already have cut the prices of their AIDS and heart-disease drugs in the hope of dissuading Thailand from switching to less-expensive alternatives. Thailand still could choose to import generic drugs to replace Abbott's, however, just as it is now using generic versions of Merck's AIDS drug Efavirenz, despite Merck's own move to lower prices. Big drug companies have been pushing sales in emerging markets like Thailand, in part, because of a backlash against expensive brand-name drugs in the U.S. and other Western markets. Merck expects revenue in emerging markets to double by 2010 to more than $2 billion a year. Abbott's international pharmaceutical sales totaled $1.68 billion in the first quarter of this year -- nearly as much as its $1.69 billion in U.S. sales. In 2006, Abbott's total sales in the U.S. dropped 7.5% to $11.5 billion, while the company's international revenue rose nearly 11% to $10.9 billion.

Remédios sem médicos e enfermeiros: um dilema africano

Plos Medicine publica um estudo sobre a disponibilidade de medicamentos para aids, malária e tuberculose em países com um número reduzido de médicos e enfermeiros. Os autores fazem paródia com com o movimento Medicine sans frontiers, lançando o Medicines without Doctors, que chamei de Remédios sem médicos e enfermeiros. Ou seja, mesmo com o apoio de fundos beneméritos (Melinda e Bill Gates, p.ex) e a cooperação da Big Pharma (sem ironia), o problema continua, porque há necessidade de uma estrutura mínima. Vou continuar ainda essa semana, discutindo artigo de Laurie Garrett na Foreign Affairs sobre o tema, mas já discuti a situação de Gana (exportação de médicos) e da Nigéria (resistência à vacinação) como exemplos da difícil situação da África.O texto é Ooms G, Van Damme W, Temmerman M (2007) Medicines without Doctors: Why the Global Fund Must Fund Salaries of Health Workers to Expand AIDS Treatment. PLoS Med 4(4): e128 doi:10.1371/journal.pmed.0040128 e, a conclusão segue abaixo.
Both the cases of Mozambique and Malawi illustrate the crucial importance of addressing the health workforce crisis. It is easier to remedy the shortage of medicines with external funding than it is to remedy the shortage of health workers with external funding. Medicines can be bought; health workers need to be trained first. This underlines the importance of starting emergency human resources programmes now, before the growing case load—resulting from the fact that most people on ART will stay alive longer, while the number of people in need of ART will grow—undermines either the quality of ART programmes, or the performance of health systems. Without support from the Global Fund, it will be difficult for Mozambique to develop its own emergency human resources programme. Bilateral donors are unable to support human resources programmes that rely on sustained external assistance over decades. The World Bank is unwilling to use foreign assistance for salaries of health workers. The IMF is unwilling to stretch ceilings on wage bills, because commitments from bilateral donors are unreliable. Without flexibility about these ceilings, bilateral donors cannot support salaries of doctors and nurses, even if they want to. It is a vicious circle. The Global Fund is probably the only actor able to break through this vicious circle. It is the only donor mechanism that benefits from an explicit endorsement from the international community to practice a novel approach to sustainability.But donors must give the Global Fund the resources to do so. As one of us argued in a previous article, it is feasible to turn the Global Fund into a world health insurance, funded by rich countries in accordance with their wealth, and creating rights for poor countries to obtain assistance in accordance with their needs. It would allow individual donors to overcome their inability to make commitments beyond the term of their governments, because their contributions would be compulsory. (This is not a heresy. Many bilateral donors consider their contributions to the World Bank as compulsory. This can be achieved for contributions to the Global Fund.) Furthermore, the pooling of resources by many donors would increase continuity: if one donor reduces its contribution, another donor could compensate.And that is exactly what countries like Mozambique need to increase their health workforce: sustained assistance.

O almoço grátis novamente: agora a avaliação de projetos de pesquisa.

Jerry Avorn, professor de farmacoepidemiologia da Harvard Medical School começa seu artigo no The New England Journal of Medicine (Paying for Drug Approvals — Who's Using Whom?) da seguinte forma: "Anos atrás, um diretor de hospital regional explicou me como as reuniões clínicas no seu hospital estavam funcionando bem: " a indústria farmacêutica traz o conferencista, paga seus honorários e o almoço dos médicos que por sua vez garantem audiência". Isso funciona para nós com orçamentos tão apertados" . Avorn utiliza esse exemplo corriqueiro para avaliar outro problema mais sério: o pagamento das indústrias ao FDA para analisar seus processos. De início, parece justo, mas depois há um confusão, que o autor questiona: afinal quem está pagando quem? A questão é polêmica, porque no Brasil não é permitido pelo Conselho Nacional de Saúde, o pagamento às comissões de ética em pesquisa por parte da indústria, para avaliarem uma quantidade grande de projetos originados na própria indústria. Os avaliadores está recebendo, na maioria das vezes salário da própria instituição. Trata-se de um tema que não permite respostas simples.

Outro tema, esse sim com resposta fácil é o almoço grátis oferecido nas reuniões clínicas em hospitais, principalmente os de ensino.. Algumas poucas universidades americanas já abandonaram esse hábito e, aqui ao que consta somente o Hospital Universitário da USP. Esse aspecto e outros do relacionamento indústria farmacêutica-médicos é abordado no site http://www.nofreelunch.org.

O texto de Avorn pode ser acessado clicando o título do post ou em http://www.nejm.org onde há mais dois articulistas analisando a questão.

Years ago, an administrator at a community hospital explained to me how well his institution's grand-rounds program worked. "The drug companies find the speakers, pay their honoraria, and provide free food for the doctors, which helps a lot with attendance," he said. "It works well for us, especially with our budgets so tight." Yet those lunches were actually quite costly for the hospital: attendees at such events predictably go on to prescribe the products promoted there — which is precisely why the drug companies so willingly pay for these programs.
This penetration of commerce into the province of science isn't limited to continuing medical education. Since 1992, the United States has relied heavily on the pharmaceutical industry to pay the salaries of Food and Drug Administration (FDA) scientists who review new drug applications. The Prescription Drug User Fee Act (PDUFA) is now up for its periodic 5-year renewal, and Congress seems ready to reauthorize it with the same short-sightedness that afflicted that naive hospital administrator.

Coragem para contestar os stents e sua indústria.

Na sessão da American College of Cardiology, que se encerra hoje, houve a apresentação de vários estudos novos, um deles chamado COURAGE. Esse estudo avaliou 2287 pacientes com angina do peito para comparar se angioplastia com stent não farmacológicos é superior ao tratamento convencional com medicamentos. Houve uma leve vantagem para o tratamento clínico, ou seja não há porque indicar angioplastia nessa situação. O texto completo está em http://www.nejm.org Abaixo segue um reportagem muito esclarecedora do The New York Times com a repercussão do estudo. Um pouco antes, a Boston Scientific que produz o Taxus - stent farmacológico - aproveitou-se da situação para lançar a idéia que o problema do estudo foi que somente 3% dos participantes teriam usado o seu produto.

By BARNABY J. FEDER Published: March 28, 2007 NEW ORLEANS, March 27 — Is today the first in a new era for angioplasty and stenting, the artery-clearing technology that enchanted doctors while giving birth to a multibillion-dollar industry? Many heart specialists at the annual scientific meeting here of the American College of Cardiology said it ought to be, based on a report Monday that found little additional value in giving stents to most heart patients as long as they received the right medicines. “We were amazed at how well people did with medical therapy,” said Dr. William Weintraub, chief of cardiology at the Christiana Care Health System in Newark, Del., who is leading the analysis of the economic and quality of life data from the trial. The trial focused on patients with severe constrictions in their arteries that were causing angina chest pains or other symptoms but were not immediately life-threatening. Device makers and some doctors, however, doubted that the trial would have broad impact. They noted several reasons to question the results, starting with the fact that only 3 percent of the stented patients in the trial received the latest drug-coated models. Those models were just reaching the market when enrollment in the study ended in 2004.
Whether the trial results lead to a change in the use of stents depends on how the doctors and patients react. In any event, the research comes as sales have already been dropping because of safety concerns.
Estimates from doctors and analysts of the number of stent patients whose conditions resembled those in the trial ranged from 20 percent to as much as 80 percent. Marshall Gordon, who follows device makers for Credit Suisse Securities in New York, said that in conversations with cardiologists, 30 percent to 40 percent of them said they would recommend less angioplasty. But, he cautioned, it was too soon to know how the practice would unfold. Dr. Salim Yusuf, a Canadian cardiologist who has argued that stents are overused, questioned how much impact the study would have. “We’re going to have a hell of a time putting the genie back in the bottle,” Dr. Yusuf said to the researchers gathered Tuesday. “It’s a $15 billion to $20 billion industry. You have huge vested interests that are going to push you back.” Dr. Yusuf was referring not just to device makers but also to interventional cardiologists, the specialists who do angioplasty and stenting. The technology was born 30 years ago when Dr. Andreas Gruentzig first used a catheter threaded into a coronary artery to inflate a tiny balloon inside a developing blockage. The arrival of a minimally invasive alternative to bypass surgery for restoring blood flow to ailing hearts led to a rush of investment in device companies. Small fortunes were made in the mid-1990s when stents were invented in response to angioplasty’s biggest shortcoming — the tendency of arteries to quickly reclose. Those fortunes became giant ones when drug-coated stents were introduced in the United States in 2003, sending the number of patients returning for repeat procedures below 10 percent. The Taxus stent from Boston Scientific, which arrived in 2004, achieved more sales in its first year than any health care product in history. By last year, more than 60 percent of the patients getting stents had more complex blockages than those the drug-coated stents had been tested on in clinical trials, according to federal regulatory officials. Then reports began emerging that deadly clots could form in the drug-coated stents long after implantation. Sales began dropping on uncertainty about the stents’ safety even though the data showed that the problem affected only a handful of patients out of every thousand. The available data, which some doctors say is inadequate, suggests that the clotting is not frequent enough to make the new stents less safe than the older bare-metal devices they have largely supplanted. A decline in sales last year reflected some switching to the cheaper bare-metal stents, but by the end of the year, the total number of procedures was falling for the first time. Now the question is whether the new trial data will accelerate the decline and make it harder for the companies to reverse with new products that might be safer. Medical therapy — which to cardiologists means a combination of modern drugs, exercise, healthy diets and almost anything else that does not break the patient’s skin — was so successful at relieving angina that Dr. Weintraub and others said angioplasty should be used as a fallback, after the drug treatments failed in patients like those in the trial. In common practice, many such patients get angioplasty and stents because they are sent to interventional cardiologists for angiograms — X-rays of the blood vessels sustaining the heart muscle. The angiogram requires inserting a thin catheter to deliver a dye to the arteries being pictured. Because the same system is used to deploy the tiny angioplasty balloons that create channels through blockages and then to implant stents to prop the vessel open, interventional cardiologists often do such procedures immediately after a major blockage is identified. “It’s very difficult to turn your back on the angiogram and not fix what’s there,” Dr. William Boden, a lead investigator in the trial, said. Yet that is exactly what the trial results suggest that doctors could safely do in patients like those studied. Two-thirds ended up not needing angioplasty and stents. The one-third whose symptoms worsened to the point that they underwent stenting or bypass surgery did not suffer higher rates of death, heart attacks or hospitalization if stenting was delayed to try aggressive medical therapy first, the trial found. In the trial, patients who received angioplasty and stents got quicker and more complete relief initially. By the end of five years, 74 percent of that group and 72 percent of the patients assigned to the medical therapy group had no symptoms of the chest pains — in essence, statistically speaking, an identical outcome. Dr. Weintraub said on Monday that the trial data suggested that the cost of gaining an additional year of improved quality of life from stenting came out to $217,000 a patient, because so many patients gained nothing. That data, however, covered such a broad range of individual outcomes that he cautioned against relying too much on it. More notably, he said, the data suggested that 1 percent of stenting patients gained an additional year of improved quality of life for less than $50,000, a commonly used standard for whether medical resources were being used wisely. But all of the researchers stressed that angioplasty with stenting was still the preferred therapy for many less-stable patients. Some doctors said they were worried that patients reading about Courage, as the new study is called, might get the wrong impression. “If someone comes in with a heart attack, you could lose vital time having to convince a patient or family member it’s appropriate,” Dr. Ralph Brindis, a cardiologist in San Francisco, said

Queda na prescrição de stents farmacológicos nos EUA

Confesso que não consegui avançar na leitura de seis artigos no The New England Journal of Medicine sobre a controvérsia dos stents farmacológicos. Era tarefa para o Carnaval. Hoje, The Wall Street Journal mostra que houve queda na prescrição dos stents farmacológicos porque os médicos passaram a temer trombose tardia. Esse problema pode ser contornado com o uso de Plavix por um ano, mas o preço alto e, sempre a possibilidade de adesão baixa ao tratamento está empurrando médicos a indicar o stent simples. Vamos ver o que está acontecendo por aqui, mas meu palpite é que não haverá modificação. A seguir, trecho da matéria, onde mostra que há médicos pensado com a cabeça e com o bolso do paciente. Coisa rara!.

Compared with bare stents, drug-coated stents reduce the need for repeat stentings, but they come with a small risk of blood clots years after a stent is implanted. To reduce that risk, patients are now urged to take the blood-thinning drug Plavix for a year after implantation. The drug-coated stents cost about $2,300 each and are highly profitable for the two companies that sell them in the U.S. -- Boston Scientific and Johnson & Johnson. Several companies sell bare stents, including Abbott Laboratories and Medtronic Inc., for roughly $800 each. Some doctors say they are now more hesitant to use drug-coated stents on poorer patients who are unlikely to be able to afford the $1,500-a-year cost of Plavix. "We've been burned by patients who don't take their Plavix," said Gary L. Schaer, director of the cardiac-catheterization laboratory at Rush hospital in Chicago, describing one patient who balked at the cost and "literally wiped out her whole heart" with a blood clot. Now, "if we suspect that patients have a history of noncompliance, or we're concerned that they won't follow directions or they just can't afford it," Dr. Schaer said he typically uses a bare-metal stent instead.

Medicamento falha, Wall Street Journal noticia.

Uma proposta revolucionária para as doenças cardíacas, o AGI-1067 (quem quiser assistir um filme fantástico sobre aterosclerose e a ação desse fármaco, acesse http://www.atherogenics.com) não teve sucesso na sua tentativa de reduzir morte e reinfarto do miocárdio. Uma pena. Esse fato ocorre a todo momento na pesquisa farmacêutica, mas cada vez mais a notícia chega pela imprensa econômica. O estudo deverá ser apresentado daqui há 8 dias em Nova Orleans, no congresso do colégio americano de cardiologia, mas hoje já sabemos do resultado pelo The Wall Street Journal.(abaixo a notícia) Talvez, esteja respondendo a uma pergunta de um amigo que questiona porque assino o WSJ e, compareço a poucos congressos. Esse é um dos motivos, a notícia chega antes, outro é que as transmissões à distância pela internet estão cada vez melhores e, a baixíssimo custo.

AtheroGenics Says Heart DrugMisses Primary Trial Target
By RON WINSLOWMarch 19, 2007 7:56 a.m.
AtheroGenics Inc. said its heart drug AGI-1067 failed to reach its primary goal in a 6,127-patient clinical trial, but that it did reduce a combination of cardiovascular death, heart attack and stroke.
The Alpharetta, Ga.-based company announced the preliminary findings this morning just eight days before scientists are scheduled to present more complete data at next week's meeting of the American College of Cardiology in New Orleans. Under the college's embargo rules, the company is forbidden from disclosing further details of the study until then.
"We're obviously disappointed we didn't meet the primary endpoint," said Russell Medford, president and chief executive officer of AtheroGenics, "but we are optimistic about the results of the trial and we do look forward to continuing development of what we think is an important drug with the goal of improving patient care."
AGI-1067 is a drug with both anti-inflammatory and antioxidant activity that the company is developing to prevent serious cardiovascular events in people at risk of heart disease.
Analysts have generally been skeptical that the drug would achieve its primary target, though many viewed it as a potential blockbuster if it did. The drug's fate likely depends on further details from the study, including the statistical strength of the possible benefits the company described.
The primary endpoint, as the main goal of a clinical trial is called, included cardiovascular death, resuscitated cardiac arrest, nonfatal heart attacks, need for bypass surgery or angioplasty to clear blocked arteries, and urgent hospitalization for acute chest pain. Patients in the trial all had a history of heart disease and all were being treated with a variety of other heart drugs, including cholesterol-lowering drugs called statins.
"We have a wealth of information that we're going through," Dr. Medford said in an interview this morning. "What we've seen is encouraging and we have determined that further development of the drug is important."
Whether that will require additional clinical studies isn't clear. Decisions will involve AstraZeneca PLC, which has a joint venture with AtheroGenics, and which will have 45 days once analysis of the data is complete, to determine whether to continue the relationship. The company also plans to hold discussions with the Food and Drug Administration.

Wall Street e o preço dos medicamentos

Não se origina de ninguém do governo, de ONGs, de partidos políticos, mas sim do próprio centro financeiro americano o questionamento do preço elevado dos medicamentos novos para tratamento para o câncer. Ruim, para os negócios concluiu o analista da Morgan Stanley.

From Wall Street, a WarningAbout Cancer-Drug Prices
Morgan Stanley AnalystCreates Stir in IndustryAs He Sees a Backlash
By GEETA ANANDMarch 15, 2007; Page A1
Two years ago, Steven Harr urged Genentech Inc. to lower the price of a key drug that was helping buoy its stock price. He was an unlikely messenger because of his job: a Wall Street research analyst whose investing clients crave profits.
In a conference room with 30 senior managers from the biotech company, Dr. Harr said he feared patients wouldn't be able to afford the drug Avastin, which costs about $47,000 for the average 10-month course of treatment for colorectal cancer. He warned that Congress "will get involved when its constituents can't get drugs." Genentech later capped Avastin's price, acknowledging the influence of Dr. Harr, among many others.
From his perch at Morgan Stanley, the 36-year-old Dr. Harr has become an important gadfly on the most controversial issue in the biotech industry: drug pricing. A burst of expensive new drugs -- routinely costing tens of thousands of dollars a year -- is boosting the fortunes of biotech companies, which say the prices reward investors, reflect the difficulty of developing these medicines and fuel vital research. But the costs are setting off a growing outcry from patient advocates, doctors and Congress, which is considering two bills aiming to bring prices down. Wall Street analysts rarely speak out for fear of alienating the companies they cover. But as Dr. Harr sees it, the high costs are bad for business. He has repeatedly argued that rising drug prices could trigger government controls, hurting the industry long term. He says soaring cancer-drug prices, generating fat profit margins, aren't sustainable.
"I do not favor government setting prices on drugs because it will stymie innovation," he says, "but it is my fear that this will happen."
Advances in research are changing cancer from a death sentence to a chronic disease for many people. That is also bringing huge new costs: In 2002, cancer drugs accounted for 13% of the nation's drug spending, according to Morgan Stanley; this year it says such spending is projected to almost double, to 22%. For now, the high prices of cancer drugs are continuing to boost the stocks of companies that make them. Indeed, investors who followed Dr. Harr's advice on Genentech stock would have missed out on a 25% surge in the two years he urged caution on the shares.
Propelled by sales of expensive new drugs, Genentech, based in South San Francisco, Calif., is one of the world's fastest-growing companies. It reported revenue of $9.3 billion in 2006, a 40% increase from 2005. Net income rose 64% in 2006 to $2.1 billion.
But a pushback on drug prices is gathering steam in the Democrat-controlled Congress. And already, the two biggest biotechs, Genentech and Amgen Inc., have taken initiatives to cap prices of certain cancer drugs.
Dr. Harr "pointed out a potential risk that wasn't completely understood by everyone," says Jay Markowitz, a surgeon and now a biotechnology analyst at mutual-fund company T. Rowe Price Group.
"What he said was relevant and it was necessary, but it was not a popular thought," adds Bill Slattery, a partner at Deerfield Partners, a New York health-care investment fund that has invested in Genentech.
Dr. Harr grew up in Omaha, Neb., the second of four children of an attorney and a journalist. Conversations at the family dinner table were often debates on issues of the day; because of his strong opinions, his father sarcastically dubbed him "the diplomat."
After graduating from Johns Hopkins School of Medicine, Dr. Harr was finishing his residency at the University of California, San Francisco, when he grew interested in biotechnology. In 2000, instead of beginning a cardiology fellowship, he headed to Wall Street. He followed a friend to the former boutique investment bank Robertson Stephens, which hired him as a junior analyst. Two years later, he moved to Morgan Stanley.
Cancer-drug prices moved to a new level of the stratosphere in 2004, when two products came to market at huge premiums over others in the field. Erbitux, made by ImClone Systems Inc. and partner Bristol-Myers Squibb Co., was introduced at $10,000 a month. That was about $40,000 for the course of treatment for the average late-stage colorectal-cancer patient for whom it was marketed.
The price shocked Dr. Harr. Biotech drugs, which are produced by live cells, were generally more expensive than pills that are a mixture of chemicals. But this was twice the price of other new cancer drugs on the market, and many times the cost of older drugs.

Genérico, não necessariamente o mais barato.

Como os consumidores brasileiros já aprenderam, em vários momentos o preço do genérico se aproxima ou mesmo supera o do equivalente de marca. Agora, esse fenômeno foi detectado nos EUA, onde a venda de genéricos está crescendo muito nos últimos dois anos. Abaixo, trecho de reportagem do The Wall Street Journal.

Why Generic Doesn't Always Mean Cheap
Zocor Case Shows DrugstoresMay Offer Only Small SavingsOver Brand-Name Drug Prices
By SARAH RUBENSTEINMarch 13, 2007; Page D1
The great promise of cheap generic drugs is taking a bumpy road to arrival.
Case in point: Zocor, one of the most commonly prescribed pills in the U.S., which lost patent protection last June. Multitudes of patients have switched to generic versions of the cholesterol-lowering drug, lured by lower insurance co-payments or the promise of a significant price drop for those who pay out-of-pocket.
As predicted, the price that many insurers pay for generic Zocor has dropped dramatically. But the price that pharmacies charge patients who pay cash remains high in many locations, with wide variations by vendor. At online pharmacy walgreens.com, for instance, the price for 30 tablets of a 20-milligram dose of Merck & Co.'s Zocor is $149.99, compared with $89.99 for simvastatin, the generic version. And last week, the same dose of simvastatin cost $108.99 at CVS's Web site, compared with $154.99 for Zocor. After a call from a reporter, CVS said it would drop its simvastatin price to $79.99, as part of an "ongoing price analysis."
At a time when policy makers are searching for ways to cut health-care costs, generic drugs are often viewed as one of the most straightforward solutions. But as the situation with generic Zocor illustrates, prices can vary wildly, and may not be nearly as cheap as expected. Generics of a number of other notable drugs that came off patent recently -- including the antidepressant Zoloft, the antibiotic Zithromax and allergy drug Flonase -- have also so far failed to deliver big savings in many cases.
"We're not seeing that sharp a drop-off" in price among generic drugs that have come out in the past couple of years, says Jim Yocum, executive vice president of DestinationRx Inc., a Los Angeles pharmacy data and software company. "We're just not seeing it."
To be sure, even for the uninsured, generics still typically cost less than their branded counterparts. And at big clubs such as Costco Wholesale and Sam's Club, out-of-pocket prices for generics do generally plummet. Simvastatin costs $6.97 for 30 pills of the 20-milligram dose at a Sam's Club for which the company provided price information.
But just how far -- and how fast -- generic prices fall depends on a number of factors. Among them: how many generics makers sell the drug; how much competitive pressure pharmacies feel; whether there is another alternative, such as a different generic in the same class of drugs; and whether a particular generics maker gets an initial exclusivity period. By law, the first generics maker to challenge a patent on a branded drug and prevail wins six months of exclusive sales.
For the more than 46 million Americans without health insurance -- plus perhaps millions more whose insurance plans don't cover drugs -- the lesson is to shop carefully. Some pharmacies list prices online, and certain Web sites will compare prices from a number of competitors. If your pharmacy doesn't list prices, a few phone calls to some competitors can mean big savings. If you're willing to travel, try pharmacies that aren't very close to each other and are less likely to react directly to each other's prices.
The growing variety of outlets for prescription drugs -- with wholesalers and online vendors joining the chains and mom-and-pops -- brings a range of business models that affect how generics are priced. At sellers where drugs are a significant driver of revenues, prices may remain high. Sometimes, as with generic Zocor, prices stay high even after a six-month exclusivity period ends, when additional generics makers start fueling supply.
Stores say they regularly review prices. At drugstore.com, generic simvastatin until recently had been at $125 for the common 30-tablet dose, compared with $135.99 for Zocor, even after the six-month exclusivity period ended in late December. After a reporter called to inquire about the price, drugstore.com on Friday dropped simvastatin to $27.99, which the company said was part of a regular review. Zocor now costs $139.99. On walgreens.com, simvastatin's price hadn't fallen after the six-month period's end. After a reporter inquired about it in late February, it dropped to $89.99 from $129.99. A spokeswoman said the price had already been under review.

STF bate de frente com a Máfia das liminares de remédios de alto custo.

A Ministra Ellie Gracie do Supremo Tribunal Federal concedeu liminar há 10 dias que vai impedir a cristalização da jurisprudência sobre medicamentos de alto custo no país. Quem solicitou e recebeu essa determinação foi o Estado de Alagoas. Há Estados endividados devido ao abuso da indústria de liminares para garantir o recebimento de medicamentos de alto custo. Segundo a Ministra "está se reduzindo a possibilidade de oferecer à comunidade a atenção básica". Como funciona o esquema:

(1) a indústria percebe logo que o custo do medicamento não pode ser pago por pessoa física e nem coberto por plano de saúde. De início, tenta junto ao Ministério o seu cadastramento em algum tipo de programa.Mas, na maioria das vezes, não obtém sucesso.

(2) com a negativa oficial, a indústria financia agências de publicidade, assessorias de imprensa, médicos e ONGs de pacientes para atuar na corrente favorável ao medicamento. Capas de revistas, seminários e artigos do tipo você pode ter______, pergunte ao seu médico são estimulados ao máximo;

(3) em hospitais e clínicas particulares, o médico é estimulado a prescrever o medicamento de alto custo. Na porta, o propagandista informa que a única solução é com ação judicial e, indica advogado .....até conseguir a liminar. (Na praça Oswaldo Cruz em São Paulo, havia uma faixa entre dois postes com os dizeres: "Interferon peguilado: sentença judicial rápida. Fone:9xxx.xxxx.)

(4) quando secretários de saúde vão a público reclamar do abuso das liminares, a assessoria de imprensa lança em jornal artigo assinado por médico subvencionado pela empresa jurando que aquele medicamento é tão revolucionário quanto a penicilina ou a anestesia. Ou então publica carta lacrimosa de um pai afirmando que o secretário é um sujeito pérfido etc etc e, que se fosse o filho do secretário as coisas seriam diferentes.

Enquanto isso, quem está fora do esquema fica sem penicilina e anestésicos.

Mudança na bula do eritropoiéticos: FDA acorda

O sonolento FDA parece que está um pouco mais atento, depois da mudança no Congresso americano, onde é votado o orçamento do órgão. Hoje, lançou uma advertência sobre os medicamentos que aumentam a produção de glóbulos vermelhos em pacientes renais crônicos. O resultado foi a queda das ações das farmacêuticas. Abaixo, a declaração oficial.

The U.S. Food and Drug Administration (FDA) today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia. The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). (ESAs are genetically engineered forms of the naturally occurring human protein, erythropoietin. Natural erythropoietin is made by the kidney and increases the number of red blood cells).
FDA and the manufacturer of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks.
Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.
In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery. "The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies," said Steven Galson, MD, MPH, director of FDA's Center for Drug Evaluation and Research. "The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting." Safety concerns from earlier ESA studies were discussed during a 2004 meeting of the ODAC. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information. The three drugs are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients. ESAs are not approved to treat the symptoms of anemia – including fatigue – in cancer patients, surgical patients, or those with HIV. All three drugs are manufactured by Amgen Inc. of Thousand Oaks, California. Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson

Tekturna, algo novo da Big Pharma para hipertensão

Finallmente, algo novo da Big Pharma para hipertensão - o aliskiren - da Novartis,nome comercial Tekturna, aprovado nos Estados Unidos. Trata-se de um inibidor da renina, o primeiro produto desse grupo. Agora, é verificar o quanto adicionará ao tratamento atual e, evidentemente o custo. Abaixo uma descrição do produto.

Tekturna(R) - The First New Type of High Blood Pressure Medicine In More Than a Decade - Receives Its First Approval in the US
Mar 5 2007, 8:20 PM EST PRNEWSWIRE
EAST HANOVER, N.J., March 6 /PRNewswire/ -- Novartis announced today that the United States has become the first country in the world to approve Tekturna(R) (aliskiren) tablets, the first new type of medicine in more than a decade for treating high blood pressure -- a condition estimated to affect nearly one billion people worldwide and remains uncontrolled in nearly 70% of patients.
The Food and Drug Administration (FDA) issued the approval for Tekturna as the first in a new class of drugs called direct renin inhibitors. A once-daily oral therapy, Tekturna acts by targeting renin -- an enzyme responsible for triggering a process that can contribute to high blood pressure. This condition is a leading contributor to cardiovascular disease, considered the world's leading cause of death. Tekturna received FDA approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. The use of Tekturna with maximal doses of ACE inhibitors has not been adequately studied. Tekturna is expected to be available in March in pharmacies as 150 mg and 300 mg tablets. "Renin angiotensin system activity contributes to many of the complications associated with high blood pressure," said Marc A. Pfeffer, M.D., PhD, Professor of Medicine, Harvard Medical School and Cardiologist, at Brigham & Women's Hospital. "By inhibiting this important system at its origin, renin production, a direct renin inhibitor, such as Tekturna, offers an exciting therapeutic option for treating hypertension." In an extensive clinical trial program involving more than 6,400 patients, Tekturna provided significant blood pressure reductions for a full 24 hours. Furthermore, Tekturna provided added efficacy when used in combination with other commonly used blood pressure medications. In clinical trials, the approved doses of Tekturna were generally well tolerated and the most common side effect experienced by more patients taking Tekturna than patients taking a sugar pill was diarrhea. Other less common reactions to Tekturna include cough and rash. Tekturna should be discontinued as soon as pregnancy is detected as it may harm an unborn baby, causing injury and even death. Women who plan to become pregnant should talk to their doctor about other treatment options before taking Tekturna. Angioedema has been rarely reported in patients taking Tekturna. "Many patients require two or more medicines to control their blood pressure. As a new treatment approach, Tekturna has the potential to help these patients manage their disease," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Tekturna demonstrates our commitment to developing innovative medicines to help the millions of patients suffering from high blood pressure." Novartis is committed to conducting a large outcome trial program to evaluate the long-term effects of Tekturna and direct renin inhibition. Tekturna was developed in collaboration with Speedel

Merck Sharp & Dhome forçava a barra para impor a vacina para o HPV.

Notícia do The Wall Street Journal (abaixo) revela a ação da empresa Merck (no Brasil, Merck Sharp & Dhome) em forçar que os Estados americanos tornassem o Gardasil, vacina para o HPV, fator de risco para o câncer de colo uterino, obrigatório para adolescentes. A reação dos pais e educadores foi grande o suficiente para que a empresa suspendesse o lobby nos Estados.

Aqui, haverá uma reportagem de capa em um das semanais, uma reportagem de duas páginas em um dos três grandes jornais e, um hospital jetset irá abrir uma clínica de HPV. Aguardem.

Já foi dito aqui que a vacina será disponível em Brasília, mas não em Brasília Teimosa em Recife.

Merck Suspends Campaign to MakeGardasil Vaccination Mandatory
By JOHN CARREYROU and SARAH RUBENSTEINFebruary 20, 2007 6:39 p.m.
Merck & Co. said it would stop lobbying states to pass laws requiring that preteen girls be vaccinated against cervical cancer in the face of a growing backlash among parents, physicians and consumer advocates.
Merck's aggressive lobbying campaign was intended to boost sales of its Gardasil vaccine, which received Food and Drug Administration approval last year. Gardasil provides protection against two strains of the human papillomavirus that are thought to cause the majority of cervical-cancer cases.
But unlike a number of other diseases that U.S. schoolchildren are required to be vaccinated against, HPV isn't an airborne virus that can spread easily in a group setting. Rather, it is sexually transmitted. Gardasil also stands apart from other vaccines that are compulsory because of its high cost: $360 for a three-dose regimen.
In recent weeks, opposition to state mandates has grown among parents who want the freedom to make such a medical decision on their own and are worried about exposing their children to the unforeseen side effects of a new vaccine. Physicians and consumer advocates have also questioned the need to immunize young girls against a disease that is no longer very prevalent in the U.S. and doesn't develop until much later in life.
Merck's lobbying efforts have become a distraction from the company's goal of immunizing as many women as possible against cervical cancer, said Richard Haupt, Merck's executive director of medical affairs. Merck has "decided at this point not to lobby for school laws any further."
More than 20 states have drafted bills that would make vaccination of pre-teen girls against HPV compulsory. Earlier this month, Texas Gov. Rick Perry issued an executive order mandating that the vaccine be administered to all girls entering the 6th grade in the state as of September 2008. One of Merck's lobbyists in Texas is Gov. Perry's former chief of staff, and Merck's political action committee contributed $6,000 to the governor's re-election campaign.
Merck has also been funding Women In Government, a Washington, D.C.-based advocacy group made up of female state lawmakers. An executive from Merck's vaccine division, Deborah Alfano, sat on Women In Government's business council last year, and a number of the bills across the country have been introduced by members of the group.
A spokesman for Merck, Ray Kerins, declined to say how much money the company had spent on the lobbying campaign. Merck is eager to build Gardasil's sales quickly to offset patent expirations on some of its bestselling drugs and its mounting legal costs over its withdrawn painkiller Vioxx.
"It's a good decision because I think it's true that the discussion about mandates was a distraction -- it is a distraction," said Joseph Bocchini, chairman of the committee on infectious diseases of the American Academy of Pediatrics. Dr. Bocchini said he was concerned that parents would decide against vaccinating their children because of the controversy when they might have otherwise opted to do so. Merck recently asked Dr. Bocchini about his opinion on the controversy, he added.
Dr. Bocchini noted that state mandates are usually passed to control the spread of a highly infectious disease like chicken pox. The focus with Gardasil at this point should be on educating patients about the vaccine and cervical cancer, and making sure that patients can afford the vaccine, he said.
Merck's marketing campaign for Gardasil has emphasized that cervical cancer is the second-leading cancer among women around the world. But screening with Pap smears has dramatically reduced the disease's incidence in the U.S. The American Cancer Society estimates that 3,670 American women will die from cervical cancer this year, the equivalent of 0.65% of U.S. cancer deaths. Cervical cancer is a much bigger problem in the developing world.
Moreover, inoculation with Gardasil won't obviate the need for regular Pap tests because some 30% of cervical cancers are thought to be caused by other HPV strains not covered by the vaccine.

J&J e Ethicon do Brasil: quero certidão negativa do Brasil.

A Johnson & Johnson declarou nos Estados Unidos que um de seus executivos prevaricou em países não identificados com produtos da Ethicon. Como a Ethicon atua em quase todos os hospitais do país, gostaria muito de ver uma declaração negativa oriunda da matriz isentando os executivos brasileiros da empresa. A ANVISA precisa agir de imediato, afinal estamos todos sob suspeita: órgão regulador, a filial brasileira, gestores públicos e privados e dirigentes hospitalares. Abaixo, artigo de The Wall Street Journal sobre o tema.

J&J Reports Improper Payments
Drug Firm Tells RegulatorsOf Expenditures Overseas;A Senior Executive Resigns
By AVERY JOHNSON, KARA SCANNELL and JON KAMPFebruary 13, Johnson & Johnson said it alerted federal officials to improper overseas payments and that one of its senior executives is resigning over the probe.
The New Brunswick, N.J., health-care conglomerate voluntarily told the Department of Justice and the Securities and Exchange Commission that it believes its subsidiaries made improper payments in two countries regarding the sale of medical devices. Michael J. Dormer, world-wide chairman for Medical Devices & Diagnostics, stepped down as a result of the revelations. Mr. Dormer had been in charge of several medical-device divisions, including Ethicon, Ethicon Endo-Surgery and DePuy.
The company didn't name the countries involved. A J&J spokesman declined to comment beyond the press release, which said that Mr. Dormer told the company in a letter that he has "ultimate responsibility by virtue of my position" for the subsidiaries involved in the disclosure. The J&J spokesman said Mr. Dormer was not available. An SEC spokesman declined to comment.
Get alerts for breaking news -- such as Fed moves, major world events and big mergers -- delivered straight to your desktop. Alerts will appear in a small window on your screen, much like an instant-messaging window. The disclosures are a bitter pill for a company that prides itself on its clean corporate image. It was not immediately clear whether the probe extended beyond the countries, which J&J described as "small" markets, or what specific allegations or subsidiaries it involves. But J&J said that the payments in question may fall within the jurisdiction of the federal Foreign Corrupt Practices Act, which prohibit improper payments to foreign officials in order to win or keep business.
The Justice Department and SEC have stepped up their pursuit of foreign-bribery cases in recent years, including a record $28.5 million collection against Titan Corp. in 2005. Titan pleaded guilty to settle allegations involving improper payments to Titan's agent in Benin, Africa, some of which were passed on to the re-election campaign of the country's then-president, according to government papers. The government alleged that Titan paid the money in an effort to win higher fees for a telecommunications project.
Other companies have reached settlements, which generally involve deferred-prosecution agreements with federal prosecutors where the company or its subsidiary agrees to settle the allegation instead of facing an indictment. In a deferred-prosecution agreement, an indictment is usually filed but is dismissed if the company adheres to the terms of its settlement. As part of a joint settlement, most companies also agree to have a corporate monitor in place to inspect internal controls and book-and-record keeping. The SEC and Justice Department have several open joint investigations.
Johnson & Johnson has a huge medical-devices business, with products ranging from replacement hips and knees to blood glucose meters and drug-coated heart devices. The company's Medical Devices & Diagnostics division registered $20.28 billion in sales last year, about 38% of total corporate sales. Device sales were split about evenly between the U.S. and international markets.

Pague seu almoço, doutor!

The New York Times divulga o Projeto Prescrição destinado a acabar com os famosos almoços de divulgação onde a indústria farmacêutica divulga seus produtos. Nos EUA com comida chinesa, aqui com sanduíches de quinta categoria. Yale, Penn U e Stanford já proibiram essa prática. Aqui, o Hospital Universitário da USP há mais de dois anos decidiu encerrar a festa e, pagar ele mesmo lanche de reuniões científicas com produtos de melhor qualidade. Ganham todos, dos pacientes aos acionistas da Big Pharma e, principalmente a academia. Aliás, pagar o próprio almoço é um exercício de autonomia. Perdem os marqueteiros, sales rep e, padarias de qualidade discutível. A Universidade e a Big Pharma necessitam colaborar, mas em pesquisas científicas e de incorporação tecnológica. Lanche ruim, caneta, bloco de notas e canecas definitivamente não agregam valor ao produto acadêmico. Porém, pior do que uma caneta que dura dois dias e uma baguete insossa com patê de fígado é a prática de autoria disfarçada de artigos científicos de pesquisas da própria indústria.

Doctors and Drug Makers: A Move to End Cozy Ties
By STEPHANIE SAUL Published: February 12, 2007
More Hippocrates, less Hunan hot sauce. Free lunches for doctors are under attack yet again.
Free lunch deliveries to medical offices, along with those ubiquitous drug company logo pens, have come to symbolize the extensive financial ties between doctors and the drug industry. And there is evidence they influence which drugs are prescribed.
But pressure is building against the widely reported gifts and other potential conflicts, an effort that took hold last year when a group of influential doctors condemned financial arrangements between doctors and drug companies in The Journal of the American Medical Association.
Tomorrow, a new push is scheduled to be announced by Community Catalyst, a health care consumer advocacy group based in Boston, and the Institute on Medicine as a Profession, a research group at Columbia University.
With a $6 million grant from the Pew Charitable Trusts, the organizations plan a national campaign calling for restrictions on the interactions between doctors and drug companies, and urging doctors to base their prescription writing more on medical evidence than on marketing.
“If you’ve been in the waiting room when these Chinese lunches are taken into the back office, it may raise the question whether the decisions are based on the best scientific evidence about medication or whether or not those Sichuan shrimp have something to do with the prescribing patterns,” said Jim O’Hara, the managing director of policy initiatives at Pew.
The pharmaceutical industry spends $12 billion a year marketing to doctors, and much of that money is in the form of free samples delivered to doctors’ offices, often accompanied by lunch for the entire staff. When the University of Michigan health systems banned such lunches in 2005, they calculated that the lunches had been worth $2.5 million a year.
The free drugs are samples of the newest and most expensive branded products. The drug industry hopes that by starting patients with free samples, they will remain on the more expensive medication rather than using a cheaper generic. And there is evidence that doctors who have relationships with the pharmaceutical industry prescribe more of the expensive drugs.
The new initiative, called the Prescription Project, is an outgrowth of an article published in January 2006 in The Journal of the American Medical Association in which a coalition of scholars and doctors proposed that academic medical centers across the country take the lead in restricting interactions between doctors and the health care industry.
Several medical centers, including those at Yale, the University of Pennsylvania and Stanford, have announced such restrictions.
The Prescription Project aims to spread those restrictions to other academic medical centers, doctors’ organizations and third-party payers.
Some medical school deans are reluctant to impose such restrictions, fearing that they will lose research money, according to David J. Rothman, an author of last year’s journal paper who is also president of the Institute on Medicine as a Profession. “They say, ‘If we did this, we would lose a third of our faculty. They’ll go to places with less stringent requirements; if we did this, we’ll tick off the drug companies and there’ll be payback,’ ” said Professor Rothman.
One of the group’s plans is to document the impact of changes at Yale, the University of Pennsylvania and Stanford. “Did the drug companies stop giving Penn research money?” he said. “I don’t for a minute believe that is going to happen.”
The organization’s goal is not to prohibit research grants or consultancies, but to limit gifts, travel fees, speakers’ bureaus and ghostwriting while at the same time encouraging prescriptions based on a medical evidence.
“Gifts bring with them the felt need to reciprocate,” said Professor Rothman, who teaches social medicine at Columbia.
“We’re not saying you’re being bribed,” he added. “We’re saying you’re being gifted. Some of it could be raw monetary hustling. But some of it is this psychological — ‘Well, they just sent me out to Las Vegas, their drug is as good as anybody else’s, why not just say thank you.’ ”