Talking about…
2003; Elsevier BV; Volume: 1; Issue: 10 Linguagem: Inglês
10.1046/j.1538-7836.2003.00280_1.x
ISSN1538-7933
Autores Tópico(s)Drug-Induced Hepatotoxicity and Protection
ResumoSubsidiaries of Baxter International Inc. and Cerus Corporation announced that the companies reached agreement with the US Food and Drug Administration (FDA) on steps for regulatory approval for their pathogen inactivation system for platelets. Baxter and Cerus have been in ongoing discussions with the FDA throughout the submission of their modular application for their pathogen inactivation system for platelets. The steps that have been agreed upon include conducting a supplemental platelet transfusion study and performing additional analysis of the US Phase III clinical trial data. The clinical trial will be carried out using the commercial set and will provide additional data to address FDA questions related to platelet performance in the US Phase III clinical trial. http://www.baxter.com Chiron Corp. announced that its Procleix test for the detection of the West Nile virus in blood supplies is now being shipped to blood centers in the USA, making the test the first of its kind available. While the test has not been given formal approval by the US Food and Drug Administration (FDA), the agency cleared the blood test for use throughout the country under an investigational new drug (IND) application about three months ago. In November 2002, after learning that the mosquito-borne virus can be transmitted through blood transfusions, the FDA began pressing for the development of a test for use with donated blood supplies. The need for such a test was a particular priority given that only about 20% of people infected with West Nile virus have symptoms, making it difficult to weed out infected blood donors using noticeable signs of ill health. http://www.chiron.com Neither drug companies nor herbal-supplement makers have shown much interest in studying the potential dangerous interactions that may occur when people take both conventional medications and herbal remedies. Researchers at the UK's Peninsula Medical School sent surveys in October 2001 to the heads of research and development at the top 14 herbal supplement makers and the top 30 pharmaceutical companies by market share. They asked the companies whether drug–herb interactions were considered important and whether studies of those interactions were conducted. The survey also asked whether funds were specifically set aside to study the topic, and if so, how much of the 2000 research and development budget was allocated. Only 15 companies overall replied fully to the questionnaires. Another five responded but did not fill out the survey completely, and 24 did not respond at all. Sixty-seven per cent of the responding companies considered herb–drug interactions to be important, but only three manufacturers (20%) said they had conducted studies, and only two regularly allocated funds to such research. Those companies, both supplement makers, set aside 5–6% of their research and development budgets for the studies. Archives of Internal Medicine 2003; 163: 1371 Pfizer Inc. unveiled an experimental drug to help people quit smoking that could become the drugmaker's next blockbuster. In clinical trials involving several hundred smokers, the New York-based company said almost half of smokers given this oral medicine, called Varenicline, were able to quit smoking after only 7 weeks. In the same trial, only 16% of people receiving placebo managed to stop, while 33% of patients who received Zyban, a pill made by GlaxoSmithKline, and also sold as Wellbutrin for depression, were able to quit. http://www.pfizer.com Results from the African American Antiplatelet Stroke Prevention Study (AAASPS), a large multicenter trial of 1809 African American stroke patients from over 60 sites in the USA, show that aspirin is as effective as ticlopidine for prevention of a second stroke in this population. The study, sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), is published in the Journal of the American Medical Association. Originally scheduled to run until October 2003, the AAASPS was stopped in July 2002, after analyzes suggested that there was less than a 1% chance that ticlopidine would be shown to be superior to aspirin if the study were carried to completion. JAMA 2003; 289: 2947–57 To quantify the incidence of major adverse events occuring in hospital or within 30 days after surgery in patients undergoing coronary artery bypass graft (CABG) surgery and to identify risk factors for these adverse events, US researchers undertook a systematic review and analysis of studies published in English since 1990: 176 studies (205 717 patients) met all inclusion criteria. They found that the average incidence of major adverse events occuring in-hospital was death (1.7%); non-fatal myocardial infarction (MI) (2.4%); non-fatal stroke (1.3%); gastrointestinal bleeding (1.5%); and renal failure (0.8%). 30 day mortality was 2.1%. Meta-analyses show that age > 70, female sex, low ejection fraction, history of stroke, MI, or heart surgery, and presence of diabetes or hypertension are all associated with increased 30-day mortality after CABG. The researchers concluded: ‘The incidence of major adverse events in patients after CABG varies widely across studies and patient populations, and this heterogeneity must be controlled when using the literature to benchmark safety. Heart 2003; 89: 767–72 People of South Asian origin are underrepresented in clinical trials, according to findings published by UK researchers. This practice may represent a form of institutional racism, one of its authors said. Mahvash Hussain-Gambles and colleagues from the University of Leeds Center for Research in Primary Care studied the ethnicity of participants in six large-scale clinical trials conducted by the Northern and Yorkshire Clinical Trials and Research Unit. They found that South Asian participants – those of Indian, Pakistani and Bangladeshi origin – made up between 0 and 1.7% of trial participants. ‘South Asian people have higher than average national morbidity rates for asthma, heart disease, hypertension and diabetes, and there is also a huge literature on variation in ethnic minority group responses to drugs, such as hypertensives and anesthetics’, said Hussain-Gambles. BMJ 2003; 326: 1244–5 EU ministers approved a key new pharmaceuticals law increasing the number of drugs needing approval by a central body and settling a long-running data protection row between big firms and generic makers. ‘It's good both for producers and for patients, who will be able to get better access to generic products in the future', said Per Haugaard, a spokesman for the European Commission, which originally authored the bill in November 2001. The law will make all medicines for AIDS, cancer, degenerative diseases and diabetes go through a centralized approval procedure at the London-based European Agency for the Evaluation of Medicinal Products (EMEA). http://europa.eu.int The ‘Act for the Modernization of the German Healthcare System’ was introduced to the German Bundestag (Lower House). All parties concerned agreed on the target, which was to decrease the sickness fund rate to 13%. The Federal Government is planning the following measures: •Benefits from sources other than insurance, for example, maternity benefit, will be financed by taxation in future. In addition, tobacco tax will be increased by one euro per pack;•In future, the subsidizing of medicines will be 4, 6 or 8 euros, depending on the size of the pack;•The subsidies for stays in clinics will be fixed at a maximum of 12 euros per day for 14 days;•The electronic patient identity card and the electronic patient file will be introduced by 2006;•Mail order pharmacies, what are termed ‘Internet pharmacies’, are to be permitted. The prohibition associated with owning several pharmacies is to be made less strict. The act is intended to come into force on 1 January 2004. http://eng.bundesregierung.de United States Department of Health and Human Service Secretary Tommy G. Thompson announced new Food and Drug Administration (FDA) regulations to streamline the process for making safe, effective generic drugs available to consumers by limiting a drug company to only one 30-month ‘stay’ of a generic drug's entry into the market for resolution of a patent challenge. The FDA also will implement changes in its review procedures intended to help improve the speed and reduce the cost of determining that a new generic drug is safe and effective, and therefore can be made available to patients. http://www.hhs.gov The American Medical Association endorsed cloning for research purposes, saying it is medically ethical but allowing doctors who oppose the practice to refuse to perform it. ‘It makes a stance for science’, said Dr Michael Goldrich, incoming chairman of the committee that drafted the cloning report. The proposal focused on a laboratory procedure designed to create embryos to cultivate their stem cells, which are master cells that can potentially grow into any type of human tissue. Scientists believe such cells could potentially be used to treat a wide range of human diseases. http://www.ama-assn.org Smoking is not glamorous or cool. It kills. WHO calls on the worlds of film and fashion to promote a tobacco-free society and to stop helping the tobacco industry to sell a product that has devastating effects on public health: killing half its users. WHO proposes that the film industry take specific measures: stop identifying tobacco brands in films, certify that it has accepted no pay-offs from the tobacco industry, show strong antitobacco advertisements before films and implement a system rating films according to whether they show tobacco use. WHO calls on the fashion industry to take a stand against tobacco-company sponsorship, tobacco use and the promotion of tobacco as fun and glamorous. http://www.who.org Doctors are at higher risk of suicide than other people, and work-related repercussions and other barriers to depression treatment are partly to blame, according to an expert panel convened by the New York-based American Foundation for Suicide Prevention (AFSP). Even if physicians recognize that they are depressed, there are all kinds of barriers to their seeking help, some of which are irrational. The result is that physicians are not seeking help because they are afraid of punitive consequences in professional advancement, medical licensing, hospital privileges, and health and malpractice insurance. In a consensus statement published in a recent issue of the Journal of the American Medical Association, Herbert Hendin, medical director at AFSP, and associates make several recommendations including encouraging physicians to establish a regular source of healthcare and seek help for mood disorders, substance abuse, and/or suicidality. JAMA 2003; 289: 3161–6 Tomorrow's doctors will be better prepared for the complexities of prescribing modern medicines following new training recommendations produced by the British Pharmacological Society. The society has initiated new guidelines on the core curriculum for undergraduate courses because, as Dr Simon Maxwell from the University of Edinburgh says, ‘Prescribing medicines is almost the definition of what doctors do. For the vast majority, drugs represent the major treatment they can offer to their patients. Newly qualified doctors are expected to prescribe powerful medicines from day one of their clinical work. Although these have the potential to bring great benefits to patients, if used incorrectly, they can also cause great harm.’ Br J Clin Pharmacol 2003; 55: 496–503 Bertelsmann sold the specialist publishing group BertelsmannSpringer to the private equity firms Cinven and Candover. The debt free purchase price is Euro 1.05 bn. Through this transaction, Candover and Cinven are acquiring one of the world's most prestigious publishing groups for scientific and academic literature. The 70 companies that comprise BertelsmannSpringer publish 700 magazines and more than 4000 new book releases in the fields of science, medicine, economics, engineering, architecture, construction and transport each year. http://www.bertelsmann.com Allegations appeared in The New York Times on May 22 that Cutter Pharmaceuticals, a Bayer subsidiary, continued to sell factor VIII concentrate in Asia and Latin America that was not heat treated after the company began to distribute heat-treated products in North America and Europe. The article also alleges that Cutter continued to make the untreated version of its product at the same time that it was manufacturing a heat-treated version for North America and Europe. The Times article states that the Cutter documents were produced in connection with lawsuits filed by American hemophiliacs. The article notes that Cutter was not alone in distributing untreated products when treated products were available. In response to the article, Gunnar Riemann, President of Bayer Biological Products Division, wrote a letter to the bleeding disorders community, stating that The New York Times article fails to adequately explain the challenges faced nearly two decades ago during a time of tremendous uncertainty about the HIV virus, its transmission, and the potential negative impact heat-treatments could have on the safety and efficacy of life-saving blood clotting concentrates. A class-action lawsuit has been launched in California, USA, against manufacturers of clotting factor concentrate over charges that they knowingly sold products tainted with HIV and hepatitis C during the mid-1980s. The companies named in the new lawsuit are Bayer and its Cutter Biological division, Baxter Healthcare and its Hyland Pharmaceutical division, Armour Pharmaceutical, and Alpha Therapeutic Corporation. http://www.wfh.org
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