terça-feira, 20 de março de 2007
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.
Marcadores:
aterosclerose,
Big Pharma,
clopidogrel,
stent
Nem "Burat" conseguiu descrever a aids no Cazaquistão
O texto do The New York Times segue na íntrega porque revela a catástrofe vinda de pagar mal aos médicos e não ter controle da prescrição e comércio de sangue. Uma centena de crianças portadoras do HIV adquirido em transfusões de sangue desnecessárias foram diagnosticadas em localidade no Cazaquistão. Diz a reportagem que há um "racha" do valor da transfusão entre quem prescreve e o banco de sangue. Por enquanto, a caça são contra as bruxas locais. Como aquele país, é uma ditadura petrolífera tal como a Líbia, talvez eles arrangem o equivalente às enfermeiras búlgaras e o médico palestino para serem os culpados, tal como a ditadura líbia encontrou, encarcerou e condenou.
Eu faço parte da minoria que detestou "Burat", o "segundo melhor repórter do Cazaquistão". Mas, não pude deixar de associar o filme ao fato.
Doctors, and a Medical Procedure, on Trial in Kazakhstan
Justyna Mielnikiewicz for The New York Times
By ILAN GREENBERG
Published: March 20, 2007
SHYMKENT, Kazakhstan — For weeks now, Kanat Alseidov has been sitting only a few feet from the doctor on trial for prescribing a blood transfusion for Mr. Alseidov’s 2-year-old son, who had pneumonia.
Justyna Mielnikiewicz for The New York Times
In Shymkent, Kazakhstan, 100 children tested positive for H.I.V.
Two months after receiving the transfusion, the boy, a ruddy, playful toddler named Baurzhan, who tangles constantly with his twin sister, tested positive for H.I.V., the virus that causes AIDS.
“I couldn’t understand why the doctor said my son needed a blood transfusion or he would get worse,” Mr. Alseidov said. Baurzhan’s exposure to H.I.V. was only the beginning of an epidemic that has engulfed Shymkent, an industrial, car-choked city near the Uzbekistan border. Since the summer of 2006, 100 children who were treated at the children’s hospital here have tested positive for H.I.V. Twenty-one doctors are accused of medical malpractice for allowing the H.I.V. outbreak. And as the trial has progressed, it has become increasingly clear why the doctor who treated Mr. Alseidov’s son had prescribed a blood transfusion to treat pneumonia: the parents of the infected children here in Shymkent say that doctors charged patients $20 for 14 ounces of blood, splitting the proceeds with the local blood bank. A profit of up to $10 on every transfusion may not sound like much, but it is a considerable amount in a country where doctors’ salaries begin at $175 a month. While pervasive corruption encourages many unnecessary transfusions, patients frequently demand transfusions. Doctors and patients in Russia and Eastern Europe, Central Asia and parts of China and India truly believe that fresh infusions of blood can fortify a healthy body and remedy diseases that are not blood-related, say Western doctors with extensive experience in the region.
One result, Western health experts say, is that throughout Central Asia and much of the developing world, local doctors prescribe tens of millions of unnecessary transfusions, putting people at heightened risk of contracting AIDS or other diseases transmitted by blood. “It’s dumb medicine,” said Dr. Max Essex, chairman of the Harvard AIDS Institute and a professor at the Harvard School of Public Health, in a telephone interview. “One of the reactions that the medical establishment took in this country in the late ’80s, even after H.I.V. blood tests were available, was to drastically cut down the number of blood transfusions given.” All of those factors seem to have converged on the children of Shymkent. One 8-month-old boy received 25 unnecessary blood transfusions, according to court documents. The boy’s transfusion regimen was halted only in summer 2006 when he was found to have H.I.V. “It’s insane,” said Dr. Michael O. Favorov, an epidemiologist and Central Asia program director for the Centers for Disease Control and Prevention, based in Atlanta. Dr. Favorov headed an extensive medical investigation by the agency that identified the transfusions of tainted blood as the source of the Shymkent outbreak. “This kid needed no blood,” he said. Mr. Alseidov said doctors told him that no family member could provide the blood, so he went to a private blood bank. He says he was told at the blood bank that the doctor would receive half the $20 price for the blood. “Our hospitals are like a factory line,” Mr. Alseidov said. “The doctors sometimes take not even $10, but they make their money from volume.” Doctors say their low wages force them to search for ways to generate additional revenue. “Salaries are very low, and even increases don’t make a difference because of inflation,” said Dr. Amangeldy Shopaer, deputy chief physician at the Shymkent Infectious Diseases Hospital, where all 100 infected children have received treatment.
The children’s families say government neglect has compounded their predicament.
“It’s not popular to blame the government, but the evidence is clear,” Mr. Alseidov said. “Veins are not garbage bins.” Compounding their problems, families of infected children are often forced to move to seek anonymity after they are ostracized by friends and neighbors. More than half the fathers of the H.I.V.-positive children have left their families, according to family members of victims attending the trial here.
Despite the detailed American study, Dr. Shopaer maintained that the cause for the outbreak remained “not concretely known” and defended the practice of ordering blood transfusions for non-blood-related illnesses, including treatment for pneumonia. “In some cases it is required,” he said. “It depends on what kind of pneumonia.” The biggest H.I.V. epidemic in the region is in neighboring Uzbekistan, which straddles major drug-trafficking routes and where the number of reported cases has more than doubled since 2001 to 31,000, according to the World Health Organization.
Kazakhstan’s government has responded to the outbreak by firing the health minister and breaking ground on a planned pediatric AIDS facility in downtown Shymkent. Government health officials have also hired a Russian-speaking pediatric AIDS specialist from Israel to oversee treatment of Shymkent’s infected children and have completed the testing of 8,800 children throughout the country who are on record for recently receiving new blood. No new cases were found. Small outbreaks continue to haunt the developing world, however, especially the former Soviet Union, where corruption in the medical system is rampant and belief in the remedial powers of new blood runs deep. Russia alone has reported more than 200 outbreaks of H.I.V. associated with unnecessary blood transfusions. “We have been screaming and yelling since 2002, but there is limited funding to address the problems,” Dr. Favorov of the Centers for Disease Control and Prevention said. “Unfortunately before you see the thunderstorm, nobody wants to open an umbrella
segunda-feira, 19 de março de 2007
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.
Marcadores:
aterosclerose,
Big Pharma,
ensaio clínico
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