Tuesday, January 31, 2012
Depressed study subjects spell relief with Special K - FiercePharma
It isn't often that a prescription product repurposed on the street then returns to the clinic. But that's just what's happening with ketamine, sold as a generic and by Pfizer ($PFE) under the brand names Ketalar and Ketaject (and illegally as Special K). Studies testing the injectable against depression are yielding some dramatic results, described by patients in language familiar to recreational users.
Researchers from the National Institute for Mental Health and from Houston's Ben Taub General Hospital have administered ketamine to severely depressed patients with almost instantaneous results, NPR reports. Yale scientists have pinpointed a potential explanation: Ketamine appears to affect glutamate in the brain, triggering new connections among brain cells.
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"I feel that something's lifted or feel that I've never been depressed in my life," was how NIMH researcher Carlos Zarate described his ketamine patients' reactions. "And it was a different experience from feeling high. This was feeling that something has been removed." One Ben Taub study patient, who believes she got ketamine, not placebo, said she went home feeling "no more fogginess, no more heaviness." Both of them reactions that LA Weekly deemed obvious. "Any raver could have told you this," the paper said.
Ketamine has serious potential side effects, including hallucinations during its infusion--and, not insignificantly, addiction. But unlike drugs already approved as antidepressants, the injectable appears to work quickly, a big advantage for patients in crisis. Further study is on the way; the Ben Taub researchers say that if their trial shows that ketamine outperforms a placebo, they plan to conduct a longer-term study to determine whether its effects could be long-lasting.
- see the blog post at NPR
- get more, also from NPR
- see the LA Weekly postRelated Articles:
Researchers study 'Special K' drug as potential tonic for depression
Scientists believe "magic" mushrooms could effectively treat depression
Researchers take a fresh look at hallucinogens
via fiercepharma.com
Opinion: Celebrities Pushing Drugs? | The Scientist
Earlier this month, celebrity chef Paula Deen announced that she has adult-onset or type 2 diabetes, then accepted a multimillion dollar deal to promote Novo Nordisk’s type 2 diabetes drug, Victoza. Before there was Paula Deen, there was figure skater Dorothy Hamill and actor Wilford Brimley. Indeed, there has been a long line of celebrity spokespeople for pharmaceutical companies, and their track record thus far has been quite poor in terms of honesty, openness, and promoting the public’s health.
Middle-aged arthritis sufferers flocked to their doctors demanding Vioxx for pain relief after watching Hamill figure skate in TV ads touting the drug shortly into the new millennium. We now have evidence that Vioxx caused as many as 140,000 extra cases of serious heart disease in the United States during the years that its maker concealed evidence of its risks, and it was withdrawn from the US market in 2004.
All right, you say, Hamill was paid to shill for a dangerous drug. But what could be wrong with Brimley telling diabetics to check their blood sugar?
There is one group of patients with type 2 diabetes, the most common form of the disease, who need to check their sugar levels frequently and who really need those cute little machines. Those are also those (apparently including Brimley) who take insulin shots. But the majority of type 2 diabetes folks take only oral medicines or use diet and exercise to regulate their blood sugar. From those ubiquitous TV ads in the late 1990s and early 2000s, however, you’d guess that scientific studies show great health advantages to religiously using home glucose monitors.
Funny thing, though. The available research shows overwhelmingly that there’s no known health benefit to home glucose monitoring for people not on insulin. A number of large studies on improving outcomes and death rates in diabetes show consistently that tight blood sugar control is not where the action is. Rather, type 2 diabetes tends to strike through severe complications like heart attacks, strokes, kidney failure, and other diseases that basically are caused by diabetes’ effects on both large and small blood vessels. Doing things to protect yourself from those diseases—diet, exercise, stopping smoking, controlling blood pressure, and so on—improves and lengthens life in diabetics. Lowering blood sugar by itself hardly helps at all.
Don’t hold your breath waiting for highly-paid celebrity spokespersons to tell you these important medical facts on TV. And the reason they won’t is part of why the whole system of celebrities touting drugs and medical devices is unfortunate for public health. These ads don’t just sell us products. They sell us ways to think about disease. And the industry wants to be sure that the way we think about a disease is whatever way is best for pushing their sales and profits.
Physician and historian Jeremy Greene wrote about this a few years ago. He showed how the pharmaceutical industry jumped onto the preventive medicine bandwagon to convince both doctors and the rest of us to “prescribe by the numbers”—not to ask what drugs actually lengthened life or improved quality, but simply to be happy when a lab test result, such as blood sugar or cholesterol, was high and a drug made it go lower. It turns out that it’s much easier to discover and market a drug that makes your lab values look prettier than it is to find drugs that really save lives and prevent heart attacks. But most of us simply assume that lower lab numbers mean less risk and a healthier future—a connection that medical research informs us is often missing. (A great book on this frequent lack of connection is Overdiagnosed by W. Gilbert Welch.)
Now, at this point I have to add the usual disclaimer, and then a disclaimer on the disclaimer. The disclaimer is that you should treat your medical condition based on your doctor’s advice and not what you read on a blog or news outlet. If you have diabetes, for instance, find a physician that you trust and follow that physician’s advice, though you should also ask questions and feel free to do your own research.
But here’s disclaimer squared: when a drug or device company markets products to you with a celebrity spokesperson, you can be sure that the same marketing, probably on steroids, is going on behind the scenes in doctors’ offices and hospital corridors. When at least 84 percent of American doctors regularly rely on industry salespeople for critical information about drugs, the “prescribe by the numbers” message is just as ingrained in their thinking as it is in the general public’s. (The celebrities that drug companies use to brainwash doctors are not the Wilford Brimleys of the world, but rather distinguished medical school faculty physicians who happily take company money to serve on their speakers’ bureaus and to push the company marketing message.)
So, bottom line: is there something especially bad about any single celebrity deciding to shill for a particular drug or medical device, like Paula Deen telling us to eat cheeseburgers and also take good care of our diabetes? Maybe yes, maybe no. Is there a problem with how these products are marketed in the United States today? Absolutely.
Howard Brody is a family physician and medical ethicist and directs the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. He maintains a blog on the ethics of the relationship between the medical profession and the pharmaceutical industry.
Book review - How We Do Harm: A Doctor Breaks Ranks About Being Sick in America,
“My friend and colleague Otis Brawley has written a raw and honest portrayal of our health care system. There are certain to be special interest organizations and medical groups that take issue with Dr.Brawley's conclusions, but few can argue with the scientific rigor he has demonstrated in writing this book. Otis is the go- to oncologist I send so many patients to see, because he is not only a great doctor, but also a compassionate man. As we discuss the transformation of health care in this country, put Dr. Brawley's book at the top of your list.”--Sanjay Gupta, Associate Chief of Neurosurgery Grady Memorial Hospital, Chief Medical Correspondent, CNN
“Otis Brawley is one of America’s truly outstanding physician scientists. In How We Do Harm, he challenges all of us-- physicians, patients, and communities-- to recommit ourselves to the pledge to 'do no harm.'” --David Satcher,Former Surgeon General of the United States,Director, Satcher Health Leadership Institute, Morehouse School of Medicine
“Sweeping, honest and brave . . . How We Do Harm dazzles with a wealth of scientific insight, but its genius lies in the author’s recounting of individual patient stories that illuminate the dark underbelly of medicine’s missteps. Brawley does not shrink from revealing medicine’s warts, butthis book offers much more. It is a triumph of humanity and clarity in which oncology becomes a Rorschach for the practice of American medicine. You will finish this arresting book reluctantly, with a new appreciation of what American medicine could be.” --Harriet A .Washington, author of Deadly Monopolies: The Shocking Corporate Takeover of Life Itself and the Consequences for Your Health and Our Medical Future and Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present
“Dr. Brawley is a premier academic oncologist and a minority doctor in the nation's largest inner city hospital. How We Do Harm places in stark contrast the health care resources available to the rich and the poor, the insured and the uninsured, the white community and the community of color . He makes the cogent point that more testing, screening, and interventions available to the rich does not always mean better medical care .” --Bruce Chabner, MD, Director of Clinical Research, Massachusetts General Hospital Cancer Center
“Otis Brawley shares in equal measure his compelling personal story, the development of modern medical oncology, and the wide range of his strong opinions. Whether you agree with him or not, the reader is given access to Dr. Brawley’s unambiguous scientific and ethical framework. He provides an anvil for shaping your own perspectives and biases.” --Michael A. Friedman, MD, President and Chief Executive Officer, Director Comprehensive Cancer Center, City of Hope
Doctor Otis Brawley exposes the dangers of overtreatment - USATODAY.com
ATLANTA – The woman walked quietly into the busy emergency room at Grady Memorial Hospital, Atlanta's safety net hospital for the poor and uninsured. She waited four or five hours to be seen, sitting patiently on a gurney and clutching a plastic bag.Inside the bag was a moist blue towel. Wrapped inside that towel was her right breast. She was hoping it could be reattached.Doctors in the United States don't see cancer patients like this every day. A mixture of fear, poverty and lack of paid sick leave had led her to delay cancer treatment for years. Eventually, the tumor grew so large that it cut off the blood supply, causing her right breast to die and fall off, says Otis Brawley, chief medical officer at the American Cancer Society, who saw the woman in the ER that morning in 2003.In his new book, How We Do Harm: A Doctor Breaks Ranks About Being Sick in America, Brawley presents the woman's suffering as a metaphor for a rotting health system that is run, he says, "by the greedy serving the gluttonous.".
Monday, January 30, 2012
FDA staffers sue agency over surveillance of personal e-mail - The Washington Post
The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show.
The surveillance — detailed in e-mails and memos unearthed by six of the scientists and doctors, who filed a lawsuit against the FDA in U.S. District Court in Washington last week — took place over two years as the plaintiffs accessed their personal Gmail accounts from government computers.
Pharmaceutical Field - 3000 UK jobs set to go at AZ
Analysts have predicted that AstraZeneca is about to make thousands of redundancies at its two plants in Cheshire after disappointing annual results.
An official announced is expected later this week which is expected to see AZ reduce its UK workforce by around 3,000.
A spokeswoman for the pharmaceutical company declined to comment on the speculation, although AZ did release plans two years ago detailing a reduction of 10,000 global posts by 2014.
AstraZeneca, the UK’s second-biggest pharmaceutical company, has a total of 13 sites across the UK and employs around 11,000 staff.
Reports suggest AZ is set to forecast flat revenues for 2011 of around £21.3 billion and a 15% increase in pre-tax profits of approximately £8.1bn.
But the company has suffered a number of setbacks in the last twelve months in its efforts to find its next blockbuster brand. Its ovarian cancer drug olaparib was sent for further development after clinical test showed it to be ineffective. Compounds which were aimed to treat major depressive disorders also demonstrated similar disappointing results and were sent back for further research.
In the US, the company suffered further disappointment after the FDA delayed the approval of Brilinta and requested further data of the blood-thinning product before making a decision. This follows the discontinuation of motavizumab which led to a £287.2 million accounting charge, plus an additional impairment charge of £246m in Q4 of 2011 after a series of potential new products failed to materialise.
The company’s full annual results are set to be released on 2 February 2012.
Children’s A.D.D. Drugs Don’t Work Long-Term - NYTimes.com
Ritalin and Adderall, a combination of dextroamphetamine and amphetamine, are stimulants. So why do they appear to calm children down? Some experts argued that because the brains of children with attention problems were different, the drugs had a mysterious paradoxical effect on them.
However, there really was no paradox. Versions of these drugs had been given to World War II radar operators to help them stay awake and focus on boring, repetitive tasks. And when we reviewed the literature on attention-deficit drugs again in 1990 we found that all children, whether they had attention problems or not, responded to stimulant drugs the same way. Moreover, while the drugs helped children settle down in class, they actually increased activity in the playground. Stimulants generally have the same effects for all children and adults. They enhance the ability to concentrate, especially on tasks that are not inherently interesting or when one is fatigued or bored, but they don’t improve broader learning abilities.
And just as in the many dieters who have used and abandoned similar drugs to lose weight, the effects of stimulants on children with attention problems fade after prolonged use. Some experts have argued that children with A.D.D. wouldn’t develop such tolerance because their brains were somehow different. But in fact, the loss of appetite and sleeplessness in children first prescribed attention-deficit drugs do fade, and, as we now know, so do the effects on behavior. They apparently develop a tolerance to the drug, and thus its efficacy disappears. Many parents who take their children off the drugs find that behavior worsens, which most likely confirms their belief that the drugs work. But the behavior worsens because the children’s bodies have become adapted to the drug. Adults may have similar reactions if they suddenly cut back on coffee, or stop smoking.
TO date, no study has found any long-term benefit of attention-deficit medication on academic performance, peer relationships or behavior problems, the very things we would most want to improve. Until recently, most studies of these drugs had not been properly randomized, and some of them had other methodological flaws.
But in 2009, findings were published from a well-controlled study that had been going on for more than a decade, and the results were very clear. The study randomly assigned almost 600 children with attention problems to four treatment conditions. Some received medication alone, some cognitive-behavior therapy alone, some medication plus therapy, and some were in a community-care control group that received no systematic treatment. At first this study suggested that medication, or medication plus therapy, produced the best results. However, after three years, these effects had faded, and by eight years there was no evidence that medication produced any academic or behavioral benefits.
via nytimes.com
Introducing "Prescrire" in English
http://english.prescrire.org/en/SummaryDetail.aspx?Issueid=124
Prescrire is a non-profit continuing education organisation, committed to better patient care
Prescrire and Prescrire International provide independent information, by and for healthcare professionals.
For nearly 30 years, Prescrire has provided healthcare professionals – and via them, patients – with the clear, comprehensive and reliable information they need about drugs and therapeutic and diagnostic strategies.
Prescrire publishes a monthly journal in French, and an international edition in English 11 times a year, plus a yearly supplement in French devoted to drug interactions.
Prescrire is a fully accredited continuing education organisation, and offers continuing education and professional practice improvement programmes specifically adapted to the needs of healthcare professionals.
A non-profit organisation, Prescrire is wholly financed by its subscribers, and accepts no advertising or other outside support.
Prescrire publishes a monthly journal in French, and an international edition in English 11 times a year, plus a yearly supplement in French devoted to drug interactions.Prescrire is a fully accredited continuing education organisation, and offers continuing education and professional practice improvement programmes specifically adapted to the needs of healthcare professionals.
A non-profit organisation, Prescrire is wholly financed by its subscribers, and accepts no advertising or other outside support.
Open letter to Brown University re journal article misrepresenting efficacy and safety of paroxetine
The following letter to the president of Brown University requests that she writes to the editor of the Journal of the American Academy of Child & Adolescent Psychiatry supporting our request for retraction of a journal article that misrepresented the efficacy and safety of paroxetine for depressed adolescents. The letter was written by Healthy Skepticism members Jon Jureidini and Leemon McHenry and signed by additional Healthy Skepticism members and others. Jon and Leemon's campaign for retraction of the misleading article has been endorsed as a Healthy Skepticism campaign by the Healthy Skepticism international management group.
4 October 2011
President Ruth J. Simmons
Office of the President
Brown University
1 Prospect Street
Campus Box 1860
Providence, Rhode Island 02912Dear President Simmons,
Study 329: A multi-center, double blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression
We write to you about our ongoing concerns regarding a journal article that originated at the Department of Psychiatry and Human Behavior, under the leadership of Dr. Martin Keller.
Between 1993 and 1998, SmithKline Beecham (subsequently GlaxoSmithKline) provided $800,000 to Brown University for its participation in the above study.[1] The results were published in 2001 by Keller et al. in a journal article, 'Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial',[2] in the Journal of the American Academy of Child & Adolescent Psychiatry.
The article was ghostwritten by agents of the manufacturer, and seriously misrepresented both the effectiveness and the safety of paroxetine in treating adolescent depression.
While problems with study 329 and the Keller et al paper have been thoroughly exposed in legal actions,[3] the bioethical and medical literature,[4] a book,[5] and a BBC Panorama documentary[6], the paper continues to be cited uncritically in the medical literature as evidence of the efficacy of paroxetine for treatment of adolescent depression.[7],[8] Our main concern is that adolescents are being harmed because well-intentioned physicians have been misled.
Moreover, the misrepresentation has been compounded by the following:
1) The Journal was asked by two of the undersigned, Drs. Jureidini and McHenry, to retract the article, but has refused to do so.
2) In a letter of May 13, 2008, from Pamela D. Ring to Dr. David Egilman, Brown University refused to release information about its internal investigation into Dr. Keller's conflicts of interest and scientific misconduct.Study 329 reveals the pervasive influence of GlaxoSmithKline's marketing objectives on the preparation and publication of a 'scientific' manuscript and peer-reviewed journal article. GlaxoSmithKline's own internal documents disclosed in litigation show that company staff were aware that the study 329 did not support a claim of efficacy but decided that it would be "unacceptable commercially" to reveal that.[9]
The data were therefore selectively reported in Keller et al.'s article, in order to "effectively manage the dissemination of these data in order to minimise any potential negative commercial impact".9 As it turns out, the Keller et al. article was used by GlaxoSmithKline's to ward off potential damage to the profile of paroxetine and it was used to promote off-label prescriptions of Paxil® and Seroxat® to children and adolescents, some of whom became suicidal and self-harmed as a result.[10]
The unretracted article is a stain on Brown University's reputation for academic excellence. The University cannot claim to be a leader in scientific research and moral integrity while failing to act to redress this article that negligently misrepresents scientific findings.
In its accreditation document for the New England Association of Schools and Colleges (NEASC), Brown University claims in relation to 'Standard Eleven: Integrity' that 'The institution manages its academic, research and service programs, administrative operations, responsibilities for students and interactions with prospective students with honesty and integrity', that it 'expects that members of its community, including the board, administration, faculty, staff, and students, will act responsibly and with integrity', and that 'Truthfulness, clarity, and fairness characterize the institution's relations with all internal and external constituencies'.[11] The University's inaction in relation to study 329 casts doubt on the validity of these claims.
We ask that you write to the editor, Dr. Andrés Martin, Journal of the American Academy of Child & Adolescent Psychiatry supporting our request for retraction of the journal article.
We are making this letter available to interested parties and it will be posted on the Healthy Skepticism website (www.healthyskepticism.org).
Yours sincerely
Jon Jureidini
Child Psychiatrist
Clinical Professor, University of AdelaideLeemon McHenry
Department of Philosophy, California State University, NorthridgeJerome Biollaz
Professor Emeritus of Medicine, Centre Hospitalier Universitaire Vaudois, LausanneAlain Braillon
Stephen Bezruchka
Senior Lecturer, School of Public Health, University of WashingtonRuud Coolen van Brakel, director
Sandra van Nuland, consultant
Martine van Eijk, MD PhD
Instituut voor Verantwoord Medicijngebruik (Dutch Institute for Rational Use of Medicine)Marc-André Gagnon,
Research Fellow, Edmond J. Safra Center for Ethics, Harvard UniversityKen Harvey
Adjunct Senior Lecturer, School of Public Health, La Trobe University, MelbourneDavid Healy
Professor in Psychological Medicine, Cardiff University School of MedicineAndrew Herxheimer,
Emeritus Fellow, UK Cochrane Centre, OxfordJerome Hoffman
Professor of Emergency Medicine, University of Southern CaliforniaJoel Lexchin
Professor, School of Health Policy and Management, York University, Toronto, CanadaMelissa Raven
Adjunct Lecturer, Discipline of Public Health, Flinders University, AustraliaDee Mangin
Associate Professor, Director Primary Care Research Unit, Christchurch School of MedicinePeter Mansfield
Director, Healthy SkepticismDan Mayer
Professor of Emergency Medicine, Albany Medical College, New YorkDavid Menkes
Associate Professor of Psychiatry, University of AucklandRobert Purssey
Senior Lecturer, University of QueenslandNicholas Rosenlicht
Clinical Professor of Health Sciences, University of California, San FranciscoJörg Schaaber
President, International Society of Drug Bulletins (ISDB)Arthur Schafer
Director, Centre for Professional and Applied Ethics, University of ManitobaMichael Wilkes
Professor of Medicine, University of California, DavisJim Wright
Co-Managing Director, Therapeutics InitiativeLiliya E. Ziganshina
Head, Professor, Department of Basic and Clinical Pharmacology, Kazan Federal University, Russian Federation
[1] Keller M. (2011). Martin B. Keller, MD. Providence, RI: Brown University; 2011. http://research.brown.edu/pdf/1100924449.pdf
[2] Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):762-72.
[3] The People of the State of New York vs. SmithKline Beecham Corp. (Case No. 04-CV-5304 MGC), Beverly Smith vs. SmithKline Beecham Corp. (Case No. 04 CC 00590), Engh vs. SmithKline Beecham Corp. (Case No. PI 04-012879), Teri Hoormann vs. SmithKline Beecham Corp. (Case No. 04-L-715) and Julie Goldenberg and Universal Care vs. SmithKline Beecham Corp. (Case No. 04 CC 00653)
[4] Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Saf Med 2008;20:73-81. http://www.pharmalot.com/wp-content/uploads/2008/04/329-study-paxil.pdf
[5] Bass A. Side effects: A prosecutor, a whistleblower, and a bestselling antidepressant on trial. Chapel Hill, NC: Algonquin Books; 2008.
[6] BBC. Seroxat – Secrets of the Drugs Trials. Panorama. BBC one; 2007 Jan 29. http://news.bbc.co.uk/2/hi/programmes/panorama/6291773.stm
[8] Jureidini J, McHenry L. Conflicted medical journals and the failure of trust. Accountability in Research 18:45-54.
[9] SmithKline Beecham, Seroxat/Paxil adolescent depression position piece on the Phase III clinical studies, October 1998, PAR003019178; http://www.healthyskepticism.org/documents/documents/19981014PositionPiece.pdf
[10] Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry. 2006 Mar;63(3):332-9
[11] Brown University. Standard Eleven: Integrity. NEASC Accreditation; 2008. http://www.brown.edu/Project/NEASC/Standards/integrity_11.php
‘Axe hovers over AstraZeneca jobs’ | Manchester Evening News
Speculation is rife that AstraZeneca will announce hefty job losses when the drugs giant posts its annual results on Thursday.
Analysts have estimated that up to 3,000 posts could be axed across the group, which employs about 7,000 staff at two sites in Cheshire and a total of 11,000 in the UK.
Two years ago, Astra said more than 10,000 roles would be lost globally by 2014 and reports suggest the figure could be extended.
A spokeswoman for Astra said the firm would not comment on speculation.
The UK’s second-biggest medicine maker is forecast to report flat revenues for 2011 of 33.5 billion US dollars (£21.3bn) and a 15 per cent rise in pre-tax profits to 12.65 billion US dollars (£8.1bn).
It is also reportedly mulling a £2bn extension to its share buy-back programme, although it could hold back some cash for acquisitions.
Astra, led by chief executive David Brennan, has suffered setbacks over the past year in its efforts to produce new blockbuster treatments.
The company previously warned its profits would be at the low end of market expectations after an ovarian cancer drug called olaparib was held back for further development when tests revealed it was unlikely to prove effective.
Elsewhere, the results of tests on drugs for patients with major depressive disorders were disappointing although research is still ongoing.
The pharmaceuticals industry is facing a challenging period as it looks for new products and faces the loss of exclusivity on existing drugs.
AstraZeneca took impairment charges of around 381.5 million US dollars (£246m) in the final quarter of 2011 as a number of its potential new drugs fell through.
Shares are six per cent lower than their 2011 peak in May, amid fears that Astra has relatively few new drugs to replace its existing stable such as Nexium for heartburn and schizophrenia drug Seroquel, but have climbed back 20 per cent from their year-low in August.
Astra has in recent years been hampered by problems with its newest medicines after it discontinued its motavizumab drug, used to prevent serious lung disease, leading to a 445 million US dollar (£287.2m) accounting charge.
It also suffered delays in winning approval from US regulators for its heart medicine Brilinta. The US Food and Drug Administration requested further analysis into the blood-thinning pill before clearing the drug for sale.
via menmedia.co.uk
Sunday, January 29, 2012
NICE PDFs - nice!
Acutely ill patients in hospital Alcohol dependence and harmful alcohol use Alcohol-use disorders: physical complications Anaemia management in people with chronic kidney disease Antenatal and postnatal mental health Antenatal care Antisocial personality disorder Anxiety Atopic eczema in children Atrial fibrillation Attention deficit hyperactivity disorder (ADHD) Autism in children and young people Chronic kidney disease Chronic obstructive pulmonary disease (updated) Coeliac disease Colonoscopic surveillance for prevention of colorectal cancer in people with ulcerative colitis, Crohn's disease or adenomas Common mental health disorders Constipation in children and young people Delirium Dementia Dental recall Depression in adults (update) Depression in children and young people Depression with a chronic physical health problem Diabetes in pregnancy Diabetic foot problems - inpatient management Diarrhoea and vomiting in children under 5 Donor breast milk banks Drug misuse: opioid detoxification Drug misuse: psychosocial interventions Dyspepsia Eating disorders Faecal incontinence Falls Familial breast cancer Familial hypercholesterolaemia Feverish illness in children Food allergy in children and young people Glaucoma Head injury Heavy menstrual bleeding Hip fracture Hypertension Hypertension in pregnancy Induction of labour Intrapartum care Irritable bowel syndrome Lipid modification Long-acting reversible contraception Low back pain Lower urinary tract symptoms Lung cancer MI: secondary prevention Medicines adherence Metastatic malignant disease of unknown primary origin Metastatic spinal cord compression Motor neurone disease - non-invasive ventilation Multiple pregnancy Neonatal jaundice Neuropathic pain - pharmacological management Nocturnal enuresis - the management of bedwetting in children and young people Nutrition support in adults Obsessive compulsive disorder (OCD) and body dysmorphic disorder (BDD) Osteoarthritis Ovarian cancer Parkinson's disease Perioperative hypothermia (inadvertent) Peritoneal dialysis Post-traumatic stress disorder (PTSD) Postnatal care Pregnancy and complex social factors Pressure ulcer management Prophylaxis against infective endocarditis Prostate cancer Psychosis with coexisting substance misuse Referral for suspected cancer Respiratory tract infections Rheumatoid arthritis Schizophrenia (update) Sedation in children and young people Self-harm Stable angina Stroke Surgical management of OME Surgical site infection Transient loss of consciousness in adults and young people Type 2 Diabetes - newer agents (partial update of CG66) Type 2 diabetes - footcare Unstable angina and NSTEMI Urinary incontinence Urinary tract infection in children Venous thromboembolism - reducing the risk Violence When to suspect child maltreatment
Dark side of US healthcare in focus at Sundance film fest
PARK CITY, Utah: The ailing US healthcare system comes under the microscope in a documentary at the Sundance film festival that tries to diagnose what is wrong — and suggests a cure.
“Escape Fire: The Fight to Rescue American Healthcare” presents a picture of a sick, money-driven system, but argues that there is a way to reorient it towards patients while driving down costs.
The documentary, which is reminiscent of activist Michael Moore’s 2007 movie “Sicko,” is in competition at the independent film festival drawing to a close this weekend in the ski resort of Park City, Utah. “Many people feel frustrated by the healthcare that they receive now, but they don’t really understand what is wrong and how it’s broken,” Susan Froemke, co-director with Matthew
Heineman, said. “We have a disease management system, not a healthcare system,” she added, saying the film aims to show the American people “that we have to find a new way to deliver medicine.” The cost of health insurance represents 20 percent of US GDP. Americans spend $300bn a year on medicine — almost as much as the rest of the world combined — but are among the least healthy in the developed world.
“Americans and Europeans took a different direction after World War II,” cardiologist Steven Nissen, who features in the film, said, calling the US system “profit driven, instead of health driven.”
The film argues that the system encourages doctors to see as many patients in as little time as possible, leading to them over- or mis-prescribing drugs, rather than taking the time to properly evaluate patients.
“The goal was really to try to understand how the system’s broken, how there’s an entrenched, powerful group in the private sector that doesn’t want to see things change,” said Heineman.
“But there are people out there who are trying to fix it. So we both want to highlight what’s wrong with the system, and show that people are trying to make it better as well.”
The filmmakers sought out doctors, academics and others who want to develop a better way of treating patients.
They follow an injured and traumatised soldier returning from Afghanistan, who gradually manages to wean himself off of the 32 different drugs he had been prescribed, with the help of acupuncture.
They introduce Dean Ornish, a doctor known for his work on preventing cardiovascular disease by changing lifestyle and diet, in a country where 65 percent of the population is overweight.
The film also hears from the head of the Safeway supermarket chain, which has kept health insurance costs down by offering financial incentives for workers to do more sport or eat more healthily.
But while solutions do exist, Nissen laments that drug companies are more powerful than ever, notably due to a law which has virtually done away with ceilings on election campaign donations.
BBC News - Fake drugs given to NHS patients still untraced
via bbc.co.uk
Only eight people out of several thousand who received counterfeit drugs from the NHS in an incident in 2007 have been identified.
Of those eight, only three have been informed about the incident, a BBC investigation has learned.
72,000 packs of counterfeit drugs entered the UK supply chain in 2007 but 25,000 remain untraced.
Saturday, January 28, 2012
A father’s anguish: Military killed my son with prescription pad | The Daily Caller
- Latest Energy ResearchRenewable energy and climate change report from the IPCC. www.cambridge.org/renewable
A generic photo of prescription drugs taken March 20, 2009 for files. (PAUL J. RICHARDS/AFP/Getty Images)A father who has lost two sons to war told The Daily Caller that the U.S. Central Command’s policy of allowing troops to deploy with a 180-day supply of the antipsychotic Seroquel has contributed to the deaths of troops and veterans. Seroquel, he said, has tragic side effects that military leaders have ignored in their quest to combat insomnia and post-traumatic stress disorder (PTSD) among fighting men and women.
The father, West Virginia school principal Stan White, said there are better ways to treat troops and veterans who suffer from PTSD. But because the maker of Seroquel, London-based AstraZeneca, has so much influence over Congress and the military, he insisted, that peer counseling and other treatment options are being shoved aside in favor of low doses of the drug.
White’s suspicions are slowly being validated by a series of studies, legal settlements, and military rulings — including a recommendation from the Department of Defense’s own advisory body on pharmaceuticals.
“I think AstraZeneca is so strong and has so much power that no one can speak out,” said White, who has remained stoic despite his losses. “Money talks. I truly believe AstraZeneca and other big pharma companies have control over Congress.”
His first son, Army Sgt. Robert White, died in combat in Iraq. When Robert’s younger brother Andrew returned from his own tour in the Middle Eastern country, a Veterans Administration doctor prescribed a combination of Seroquel and antidepressants for his PTSD.
Andrew died at home, and the state of West Virginia ruled that an accidental medication overdose was to blame.
But his father believes the “dangerous” pill cocktail killed him. And he told TheDC that he has identified 300 other soldiers and veterans who died from sudden cardiac arrest while taking Seroquel and antidepressants in combination.
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Evidence supporting his theory has continued to accumulate, including a September 2011 study from the European Society of Cardiology which linked the “combined use of antipsychotic and antidepressant drugs” with an increased risk of sudden heart attacks.
Seroquel has been on the market since 1997, and in that time doctors have widely experimented with prescribing it for “off-label” purposes that the FDA has not approved. The drug, a mood stabilizer, is approved to treat schizophrenia and bipolar disorder, but it has also been used to treat insomnia in Parkinson’s disease patients, dementia in adults of all ages, and a variety of disorders in children.
Doctors have free rein to prescribe medications for off-label uses, and the FDA’s ever-growing avalanche of advisories sometimes makes it difficult for physicians to know what has been approved and what has not.
A 2009 University of Chicago national survey of physicians, for instance, found that one in eight doctors thought Seroquel was approved for treating dementia, even though the FDA had issued a specific warning against it.
Drug marketers, however, are forbidden to promote their products for any purpose not approved by the FDA.
In April 2010 AstraZeneca conceded that it had crossed that line, agreeing to pay the U.S. government $520 million to settle claims related to its illegal promotion of Seroquel for off-label uses.
NEXT: A massive increase in government spending on Seroquel
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via dailycaller.com
Bydureon, a Diabetes Drug from Amylin, Wins F.D.A. Approval - NYTimes.com
Analysts expect annual sales of Bydureon to eventually exceed $1 billion. But they are less enthusiastic than they once were, in part because of safety concerns involving thyroid cancer and pancreatitis.
David Kliff, publisher of Diabetic Investor, an electronic newsletter following the diabetes industry, said a once-weekly self-injection could make Bydureon an alternative for many patients to multiple insulin injections or even to multiple pills every day.
via nytimes.com
Friday, January 27, 2012
Harvard doctor calls for greater supplement regulation in NEJM | Drug Store News
WASHINGTON — The New England Journal of Medicine on Thursday published an opinion online that called for more rulemaking to govern dietary supplements in an effort to reign in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.
Author Pieter Cohen, author of the opinion and an assistant professor of medicine at Harvard Medical School, in his opening paragraph pointed to the recent recall of the product Zotrex. Marketed as a dietary supplement, the product reportedly contained the fictitious ingredient "Ophioglossum polyphyllous," but in actuality contained a drug analogue of the active ingredient in the erectile dysfunction pharmaceutical Viagra (sildenafil).
Following a Food and Drug Administration investigation of NovaCare, the company that distributed that product online, the U.S. Attorney's Office in September 2011 revealed a 31-count indictment alleging NovaCare proprietor Kelly Dean Harvey purposefully thwarted FDA regulations after the agency first started warning consumers about NovaCare products in 2009 (the product at the time was called "Stiff Nights"). Charges against Harvey include one count of conspiracy, 12 counts of wire fraud, nine counts of mail fraud and nine counts of money laundering, according to reports. He pleaded not guilty to those charges in November.
"Although Zotrex represented a particularly brazen violation of the law," wrote Cohen, an assistant professor of medicine at Harvard Medical School in the opening paragraph, "surprisingly, many new supplement ingredients are introduced into the market as [those found in Zotrex were], without any regulatory oversight." Specifically, Cohen calls for clinical trials establishing safety be a pre-requisite for new dietary ingredients to reach the market.
James Murdoch’s departure rings in changes to GSK’s board | InPharm
GlaxoSmithKline has announced that after nine years with the firm, Sir Crispin Davis, Sir Robert Wilson and Larry Culp will stand down from the board.
In addition, the UK firm said that James Murdoch has decided not to stand for re-election.
Sir Christopher Gent, chairman of GSK, said: “James Murdoch has decided to stand down from the board with effect from this year’s AGM.
via inpharm.com
MeReC Bulletin – Implementing key therapeutic topics: 1
The National Prescribing Centre has published a MeReC Bulletin (PDF), the first in a series of three, that focuses on the therapeutic areas of the QIPP agenda.
The topics covered in this bulletin are:
- Non-steroidal anti-inflammatory drugs
- Antibiotic prescribing - especially quinolones and cephalosporins
- High dose inhaled corticosteroids in asthma
For each of the therapeutic topic areas the evidence base is summarised and current prescribing data are reviewed.
EDITORIAL Of doctors and drug makers - latimes.com
Did your doctor prescribe that expensive drug solely because you need it, or in part because she has friendly feelings toward the pharmaceutical company that makes it, which treated her to a Hawaiian vacation-cum-"medical conference"? Patients may get some insight into such questions thanks to a lesser-known but important provision of the 2010 healthcare reform law that requires the makers of drugs and medical devices to disclose most payments and gifts to physicians.
The proposed regulations, which are going through a period of public comment, are appropriately strict in ways that would both protect patients and reduce medical costs. The payments and gifts would be available on a searchable public website. Free samples of drugs would be exempt from reporting, but otherwise, anything worth more than $10 total for the year would have to be disclosed.
Of course, many doctors are motivated only by the well-being of their patients, and there are times when drug company payments are appropriate and beneficial to medical research. But pharmaceutical companies are known for underwriting luxurious medical meetings for doctors that are more about play than work, and for paying physicians hefty sums to pitch their drugs to colleagues, often at lunches also paid for by the companies. Doctors with the best intentions can be influenced, consciously or not, by relentless marketing, especially when it's done by their peers.
Physicians who received research funding and other payments from pharmaceutical companies have sat on advisory boards for the U.S. Food and Drug Administrationand have recommended drugs made by those companies. A survey published in the Annals of Internal Medicine in 2010 found that 71% of doctors had accepted food from drug companies, and that doctors who took payments were more likely to prescribe those companies' expensive brand-name medications rather than cheaper generics. Fourteen percent of doctors had been paid to serve on advisory boards and enroll patients in clinical trials — and that number was half what it had been in 2004, before the practice came under greater scrutiny. Some drug companies recently began voluntarily reporting payments and gifts to doctors.
In other words, the website will be a force for good even if few patients examine it. Watchdog organizations and news reporters will use it. For many doctors and pharmaceutical companies, the knowledge that their actions will be held up to public light is enough to curb the potentially troubling behavior.
via latimes.com
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