FDA também "acha" que Avandia aumenta o risco cardiovascular.

Voltando ao tema "Avandia". Despacho dessa tarde (25/05) da Reuters é reproduzido abaixo na íntegra para revelar a absoluta confusão reinante no órgão regulador americano. Para quem acha há despreparados e incompetentes somente abaixo do Equador, ao menos um consolo. Entidades científicas estão pedindo avaliação por pares sem conflito de interesse com o tema.

FDA review also shows Glaxo diabetes drug risk

WASHINGTON (Reuters) - A U.S. Food and Drug Administration preliminary analysis found a level of heart-attack risk with GlaxoSmithKline Plc's diabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.
FDA spokeswoman Julie Zawisza stressed that other data conflicted with that finding, and officials still were weighing whether to take any action.
A Cleveland Clinic analysis released Monday said the drug increased the chances of having a heart attack by 43 percent. Speaking on the Senate floor late on Thursday, Republican Sen. Charles Grassley of Iowa said preliminary findings from an FDA analysis of Glaxo's clinical trials found a 40 percent increased risk, while the company puts the figure at about 30 percent. "Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem," Grassley said. The FDA's Zawisza confirmed that the agency's evaluation of Glaxo's clinical trials found a higher risk of about 40 percent. But she said "this alone is not conclusive" and officials are trying to reconcile that with clinical trial data that did not show an elevated risk. "We don't have the scientific data upon which to make any conclusions or decisions yet," she said via e-mail.
If a 40 percent risk were confirmed, it would mean that a person with diabetes who does not take the drug has about a 1 percent risk of having a heart attack or other, similar problem, while someone who takes the drug would have a 1.4 percent risk, Zawisza said.Grassley also said some FDA scientists recommended months ago that Avandia carry the strongest possible warning, a "black-box," about heart-attack risk. Zawisza said she could not comment on "ongoing regulatory matters" such as whether staff had recommended a black box. Grassley also said it had been reported to him that the incidence of heart attacks with Avandia could be as many as 60,000 to 100,000 from 1999 to 2006. He did not cite the source of the numbers, and experts say it is difficult to make such estimates across a broad population. The FDA's Zawisza said a relationship between Avandia and that number of events had not been established. "We don't have data to support such a conclusion," she said. GlaxoSmithKline spokeswoman Mary Anne Rhyne said Grassley's use of the estimate was "irresponsible." "They are extrapolations of extrapolations, and do not reflect reality. If these numbers were true, we would have seen them clearly" in long-term studies and databases of real-world use, she said. Glaxo has said Avandia's cardiovascular safety is similar to other oral diabetic drugs, and the benefits of treatment outweigh the risks. The FDA is continuing to review data on Avandia and plans to ask an advisory panel of outside experts for input. The Union of Concerned Scientists and several consumer groups wrote the FDA on Friday urging officials to chose advisers with no financial ties to Glaxo for the past 36 months. "By staffing the Avandia advisory committee with scientists from diverse specialties who are non-conflicted, you will send a message that the FDA cares about avoiding conflicts of interest and evaluating drugs on the basis of unbiased scientific findings," the letter said.

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

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.

FDA sob nova administração

O Congresso americano agora com maioria do Partido Democrata está atacando um dos maiores problemas na área da saúde, o Food and Drug Administration, o famoso FDA. Artigo na edição do The Wall Street Journal mostra as várias propostas em votação.

Congress is kicking off efforts to pass big reforms of the Food and Drug Administration, and that could produce some bitter pills for the pharmaceutical industry: potentially, tougher safety rules and provisions to reduce the cost of medicines.
Yesterday, Sen. Edward Kennedy of Massachusetts and Sen. Michael Enzi of Wyoming, the chairman and ranking Republican of the health committee, respectively, introduced legislation that would give the FDA new authority to impose safety requirements on medicines once they go on the market, including restrictions on consumer advertising. The bill also would require registration of clinical drug trials and their results in public databases.