Blog Tag: Adverse 
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The Other Side of The Placebo Effect
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This is the second in a pair of articles on the placebo effect.
Nocebo is sometimes referred to as “placebo’s evil twin,” or the “negative placebo effect.” It’s also sometimes described as “the other side of placebo.” The nocebo effect can be defined as a negative effect that occurs after receiving treatment (therapy, medication), even when the treatment is inert (inactive, sham).
It is important to note that negative effects seen when taking active substances, reported as drug side effects, can often be at least partly attributed to a a combination of effects from the su...
Source: World of Psychology - August 21, 2011 Category: Psychiatrists and Psychologists Authors: Jamie Hale Tags: General Psychology Research adverse Events Clinical Trials Constituents Counterpart Distinctions Evil Twin Henry Beecher Illness Outbreaks Mass Psychogenic Illness Mechanisms Medical Care Medical Symptoms Negative Response Source Type: blogs
Tips for Pharma on FacebookEmail this article to a colleague.
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Many Pharma companies are hesitant to use Facebook as a medium to communicate with their audience, and many fear it is because they will have additional worries concerning the FDA and adverse events of their drugs. Mashable recently set out and shared a few better ways for Pharma companies to communicate with their fans on Facebook while connecting with them at them at the same time.
Some of the tips:
- Know who is making the decisions about buying your product. For example, doctors are not likely to reference Facebook when searching about a drug. But for many Over the Counter drugs, consumers ...
Source: ePharma Summit - August 12, 2011 Category: Medical Marketing and PR Tags: adverse event reporting on social media Facebook Facebook Pharma Marketing Pharma Social Media Regulation Source Type: blogs
Can Pharmacogenomic Tests Help To Improve Public Health?Email this article to a colleague.
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Adverse drug events are a serious public health problem. Consider the following facts:
an estimated 82% of American adults take at least one medication and 29% take five or more;
700,000 emergency department visits and 120,000 hospitalizations are due to adverse drug events annually;
$3.5 billion is spent on extra medical costs of adverse drug events annually;
at least 40% of costs associated with adverse drug events occurring outside hospitals can be prevented.
How can genomics help? Pharmacogenomics is the study of genetic variation as a factor in drug response, affecting both safety and effectiveness. The intended app...
Source: Better Health - July 29, 2011 Category: Health Medicine and Bioethics Commentators Authors: MuinKhouryMDPhD Tags: Opinion Research Abacavir adverse Drug Effects CDC Center for Disease Control and Prevention Department of Health and Human Services FDA Food and Drug Administration Genetics Genomics HIV Treatment HIV/AIDS Pharmacogenomics Pub Source Type: blogs
Guest Blog: Health Care in Dangerous TimesEmail this article to a colleague.
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Health Care Renewal presents another guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has long observed the health care scene.Health Care Renewal has often covered the disconnect between the stated goals of companies and the realities of their day to day operations. This raised the following question: Has medicine moved from being dysfunctional to being dangerous?There is certainly no lack of material to support this question as in the last two weeks we can find examples of pharma/biotech/device companies all e...
Source: Health Care Renewal - July 8, 2011 Category: Health Medicine and Bioethics Commentators Tags: ghost writing stealth marketing adulterated drugs manipulating clinical research adverse effects public relations Source Type: blogs
Published 2 papers and 1 videoEmail this article to a colleague.
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Just recently my colleague and I have published two research papers. I am very proud of the first one titled “Mobile phone in the Chain of Survival”, which was published after a lot of research in the Resuscitation journal. This short paper gives an overview of vast possibilities possessed by mobile phones to be of assistance in medical emergencies. It represents a continuation of my work with CPR mobile applications. I have also now published a video of the lecture I gave during the Resuscitation 2010 congress about the same subject. You can watch my 10 minute lecture here, and read our paper at the Resuscitat...
Source: Ivor Kovic, M.D. - June 25, 2011 Category: Internists and Doctors of Medicine Authors: Ivor Tags: iphone medicine science adverse effects article case report chain of survival CPR croatia drugs hypertension Ivor Medical lacidipine lecture mobile paper patient porto presentation resuscitation side effects study Source Type: blogs
FDA Keeps Scolding Vaccine Maker To No AvailEmail this article to a colleague.
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If at first you don’t succeed, try, try again? Last year at this time, the FDA chastised CSL, a big maker of flu vaccines based in Australia, for flunking an inspection that found several manufacturing deficiencies and, in addition to demanding a summary of corrective actions, agency officials took the unusual step of demanding a meeting with senior execs to review their plan (back story).
Apparently, such meetings have absolutely no impact. The FDA has just issued a warning letter as a follow up to a March 2011 inspection, which generated a 483 report showing that CSL has no idea how to properly conduct an investig...
Source: Pharmalot - June 21, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events CSL CSL Biotherapies FDA FDA Warning Letter Flu Flu Vaccines Source Type: blogs
Brokers Jailed For Hiring Women For Clinical TrialsEmail this article to a colleague.
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Two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug. As many as 20 women, who are mostly farm workers and daily wagers, have developed acute joint pains, swelling in arms and throat infections.
The brokers hired the women and took them to a lab in Miyapur, Hyderabad, where blood samples were taken and they were given injections and tablets, according to reports. For their trouble, the women were paid around 3,000 to 10,000 Rupees, or roughly $65 to ...
Source: Pharmalot - June 17, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Clinical Trials India Source Type: blogs
CYA TMI? Drug Label Warnings List Dizzying Number Of Adverse EventsEmail this article to a colleague.
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Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients.
Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs.
Labels for the 200 most commonly dispensed medications contained significan...
Source: Better Health - June 15, 2011 Category: Health Medicine and Bioethics Commentators Authors: RyanDuBosar Tags: News adverse Events Confusion Drug Labels Drugs Health Literacy Legal Patient Communication TMI Source Type: blogs
SmartStrip – Low-Cost, Point-of-Care TestEmail this article to a colleague.
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A blood coagulation test (prothrombin time test) that’s as easy to use as a home glucose meter and cheaper? Wow! Over 10% of all adverse drug events ending in a hospital stay are associated with blood thinners. Because of this, regular monitoring is recommended to ensure the desired effect. Unfortunately, the current technology is either costly or must be performed by qualified technicians.
Currently, there are several point-of-care tests on the market, but the cost of the consumable test strips make it more expensive than laboratory testing. However, the SmartStrip mimics “lab on a chip” technology but ins...
Source: MD Buyline - June 14, 2011 Category: Technology Consultants Authors: james.x Tags: Cardiology adverse drug event blood coagulation coumadin SmartStrip Source Type: blogs
The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event ReportingEmail this article to a colleague.
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Once again the Brits have beaten the US in issuing useful guidelines for social media use by the pharmaceutical industry! As I reported back in April, 2011, the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), published "informal guidance" providing the drug industry advice on how to use online communications (see here).I learned today from a tweet by @dawidge (a Pfizer employee) that the ABPI Pharmacovigilance Expert Network (PEN) published GUIDANCE NOTES ON THE MANAGEMENT OF ADVERSE EVENTS AND PRODUCT COMPL...
Source: Pharma Marketing Blog - June 14, 2011 Category: Pharma Commentators Tags: ABPI adverse events Legal/Regulatory #fdasm Source Type: blogs
MRSA Vaccine Trial Is Halted, Ends In DisasterEmail this article to a colleague.
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Yesterday Reuters reported US Merck and Co have taken the very unusual step of discontinuing vaccine trials for Intercell’s MRSA vaccine. The decision was taken after experts advised the V710 vaccine was ‘unlikely to show a significant clinical benefit and expressed concerns about overall mortality and multi-organ dysfunction.’
The vaccine was set to have potential sales of more than $1.47 billion because it was to be a multi-flexible vaccine which could have been used for patients on admission to hospital, during surgery and in care homes for the elderly.
Reuters reported in a press release today:
“Me...
Source: vactruth.com - June 9, 2011 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Christina England Top Stories adverse Reactions MRSA vaccines Source Type: blogs
What Bureaucracy? FDA & A Compliance ‘Super Office’Email this article to a colleague.
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Faced with growing challenges in clinical trials, manufacturing and drug safety - among many other issues - the FDA has decided to elevate the Office of Compliance to a so-called Super Office on a par with others in the Center For Drug Evaluation and Research, such as the Office of New Drugs, the Office of Pharmaceutical Science and the Office of Surveillance and Epidemiology.
The responsibilities will include ensuring compliance with requirements for good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS, drug labeling, drug approval, drug importation,...
Source: Pharmalot - June 7, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Compliance Drug Approvals Drug Safety FDA GMP Good Manufacturing Practice REMS Supply Chain Integrity Source Type: blogs
Legal Battles Over Chantix: The Next Great Get-Rich-Quick Scheme For SmokersEmail this article to a colleague.
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Chantix lawsuits here we come. I’ve been prescribing Chantix and helping fill out forms for free Chantix for my patients for several years now. Chantix is one medicine used to help get patients to quit smoking right now. In fact, I even had a case presentation of a woman I warned to quit smoking for good or face a lifetime of being cross eyed.
Does Chantix help to quit smoking? Yes it does. It helps to take the cravings away in folks who use it. If you smoke, you should want to quit, based on my discussions with a tobacco farming insider. If nothing has helped, Chantix might be your last hope. As a ...
Source: Better Health - May 26, 2011 Category: Health Medicine and Bioethics Commentators Authors: Happy Hospitalist Tags: News Opinion adverse Events Chantix FDA Get Rich Quick Harm Law Suits Lawyers Pfizer smoking smoking cessation Suicide Varenicline Source Type: blogs
The Problem With Labeling: Too Many Side EffectsEmail this article to a colleague.
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In response to regulatory demands and mounting litigation, drugmakers have puffed up their product labeling to the point where the verbiage occupies numerous pages and contains a laundry list of possible side effects. Yet all these warnings have a down side, because they may undermine patient adherence and overwhelm docs as they try to find suitable treatments, according to a new study.
In fact, the study found that the list of potential side effects averaged 70 per drug, and the 200 most widely prescribed meds averaged 105 possible adverse events, leading to what the researchers labeled (pun intended) overwarning. The st...
Source: Pharmalot - May 25, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Drug Labeling FDA Prescription Drug Labeling Side Effects Source Type: blogs
Facebook To Pharma: Allow Comments On PagesEmail this article to a colleague.
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While the FDA continues to ponder rules for social media, Facebook is now changing its own rules and will no longer allow drugmakers to disable comments posted on newly created pages. And existing pages will no longer be able to do so as of August 15, according to InTouch Solutions.
The move reportedly came by way of email last week: “As you know, Facebook Pages are a free product for organizations, public figures, businesses, and brands to express themselves and have an authentic, engaging, two-way dialog with people on Facebook…We think these policy changes support consistency for the Facebook Pages product ...
Source: Pharmalot - May 24, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Facebook Facebook Pages FDA Side Effects Social Media Whitelisting Source Type: blogs
Mining Medical Literature To Predict Side EffectsEmail this article to a colleague.
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Could data mining medical literature uncover side effects before they cause serious harm to patients? A new study maintains the effort could effectively complement existing methods, such as combing through the FDA’s Adverse Events Reporting database, because prior research suggests that up to 98 percent of searches are irrelevant to side effects and may skew results toward false positive links.
To prove the point, two researchers from the Rank think tank developed an algorithm to sift through the PubMed literature and searched for mentions of least one of 38 drugs and 55 side effects. From there, they determined the ...
Source: Pharmalot - May 23, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events FDA FDA adverse Events Reporting Side Effects Source Type: blogs
UK Paediatrician and MSBP Expert Knew Babies Suffered Breathing Problems and Died After VaccinationEmail this article to a colleague.
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Over the last two years I have seen two documentaries both entitled ‘A Very Dangerous Doctor’. Both featured the work and research of the now discredited Professor David Southall. It has puzzled me how these documentaries failed to mention the crucial evidence of Lisa Blakemore-Brown and instead both chose to focus their attention on the work and evidence of Munchausen by Proxy campaigner and Southall hater Ms Penny Mellor.
Ms Blakemore-Brown began to speak out about this incredibly dangerous man back in 1995/1996 long before Penny Mellor had even been heard of. However, instead of the fame and glory that has b...
Source: vactruth.com - May 19, 2011 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Child Abuse Christina England Death DTP MMR Munchausen by Proxy Seizure Shaken Baby Syndrome Top Stories adverse Reactions Lisa Blakemore-Brown Penny Mellor Professor David Southall Professor Roy Meadow Sally Clark vaccine re Source Type: blogs
Succinylcholine – Adverse EffectsEmail this article to a colleague.
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Succinylcholine is a widely used drug in the operating room and intensive care units for intubation. It is considered a depolarizing muscle relaxant and thus causes fasciculations. It has a rapid onset (40-60 seconds) and is short-acting (10-15 minutes).
The adverse effect most classically associated with the use of succinylcholine (aka “sux”) is malignant hyperthermia. A partial list of other adverse effects is below
1. hyperkalemia (increase in serum potassium by 0.5 meq/L) which is exaggerated in patients with burns, myopathies, crush injuries, and denervating injuries
2. arrhythmias – can be either br...
Source: Inside Surgery - May 19, 2011 Category: Surgeons Authors: Editor Tags: Tip of the Day adverse effects bradycardia fasciculation intracranial pressure intraocular pressure malignant hyperthermia Sux tachycardia Source Type: blogs
Pfizer Did Not Report Chantix Side Effects Correctly?Email this article to a colleague.
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Adverse event data from the third quarter of 2010 show the risks of serious psychiatric side effects of Chantix, the smoking-cessation drug, were previously underestimated because Pfizer apparently failed to correctly submit hundreds of these episodes to the FDA, according to an analysis by the Institute for Safe Medicine Practices, a non-profit that regulary reviews the FDA adverse event database.
Notably, the ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly as suicides within 15 days as required. Instead, the drugmaker apparently coded the suicides as “ex...
Source: Pharmalot - May 18, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Chantix FDA Pfizer Side Effects Smoking Smoking Cessation Suicidal Behavior Suicide Source Type: blogs
How To Report Adverse Events In Trials In IndiaEmail this article to a colleague.
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Shortly after a revelation that drugmakers have not compensated survivors of most volunteers who died during studies run in India, the country’s Drugs Controller General has now issued new draft guidelines for reporting serious adverse events that occur in clinical trials. And there is also a stipulation that all info pertaining to fatalities, including compensation and care, must be reported.
A key issue, however, is that drugmakers and contract research organizations are using multiple or different formats and procedures for reporting serious adverse events to the Central Drugs Standard Control Organization, or CDS...
Source: Pharmalot - May 16, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Clinical Trials India Serious adverse Events Source Type: blogs
How can we reduce the side effects of Information Therapy ?Email this article to a colleague.
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Many medicines are available over the counter ( OTC) . These are usually safe drugs, which have been used for many years . They are effective for common problems; have few side effects; and do not need a doctor's prescription. However, most medicines are still available only with a doctor's prescription. This is because medicines can be powerful , and while they may be very good at treating certain problems, they may also have undesirable side-effects. Experts need to make a decision regarding the risk-benefit ratio of these drugs, so they can select which drugs are so powerful that they can only be dispensed with a doctor...
Source: The Patient's Doctor - May 9, 2011 Category: Obstetricians and Gynecologists Tags: Medicine Health Shopping patient Pharmacy Drugs and Medications adverse effect Prescription drug Source Type: blogs
Should Pharmaceutical Companies Get Involved In Social Media?Email this article to a colleague.
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Imagine you’re a pharmaceutical company product manager and your specific product helps people with a chronic illness, or a cancer that can be managed by taking a pill or an injectable medicine over many years. You want to be part of the dialogue patients have with each other. You want to be part of the community. Facebook users, and other social media participants, are increasingly forming groups around health conditions, big and small. You want to be there, because, after all, your company has invested hundreds of millions of dollars developing the approved drug and hopes this medicine, and perhaps a successor, will be...
Source: Better Health - April 28, 2011 Category: Health Medicine and Bioethics Commentators Authors: AndrewSchorr Tags: Health Policy Opinion adverse Event Reporting AEs Drug Facebook FDA healthcare Marketing Online Communities Pharmaceuticals Social Media Transparency Twitter Source Type: blogs
Journal of the American Medical Association 2011 (Vol. 305 No. 13)Email this article to a colleague.
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This article is a case-cohort study examining the association of maximum prescribed daily opioid dose and dosing schedule (“as needed,” regularly scheduled, or both) with risk of opioid overdose death among patients with cancer, chronic pain, acute pain, and substance use disorders. The study concludes that among patients receiving opioid prescriptions for pain, higher opioid doses were associated with increased risk of opioid overdose death.
An NHS Athens password is required to access this article online, alternatively contact the Library for a copy.
Filed under: Athens Password, Current Awareness, E-Journals, Journa...
Source: Fade Library - April 27, 2011 Category: Medical Librarians Authors: hmedley99 Tags: Athens Password Current Awareness E-Journals Adolescent adverse Analgesia Drug Prescriptions Drug Reaction Hydrocone Methadone Mortality Opioid Opioid-Related Disorders Overdose Pain Patient Safety Prescription Drugs Risk Source Type: blogs
Journal of the American Medical Association 2011 (Vol. 305 No. 5)Email this article to a colleague.
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The objective of this study is to perform a systematic review and meta-analysis of published randomised controlled trials (RCTs) to determine the overall risk of fatal adverse effects (FAEs) associated with bevacizumab, an angiogenesis inhibitor, used in conjunction with chemotherapy. The article concludes that in a meta-analysis of RCTs, bevacizumab in combination with chemotherapy or biological therapy, compared with chemotherapy alone, was associated with increased treatment-related mortality.
An NHS Athens password is required to access this article online, alternatively contact the Library for a copy of this article
F...
Source: Fade Library - April 27, 2011 Category: Medical Librarians Authors: hmedley99 Tags: Athens Password Current Awareness E-Journals Bevacizumab Cancer Drug Therapy Fatal adverse Effects Randomised Controlled Trials Source Type: blogs
Did Boehringer Mishandle This Adverse Event Report on Twitter?Email this article to a colleague.
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I follow many pharmaceutical companies (and employees of pharma companies; eg, these people) on Twitter. @BoehringerUS is one of them. To keep track of these accounts, I cross-post the tweets to this Pharma Marketing Forum (News Direct from the Pharmaceutical Industry), which automatically sends me a daily email message telling me what's been posted there. It's a good way for me to filter through all the tweets from the over 2,500 people I follow on Twitter.Today, I received notice of the following tweet from @BoehringerUS:@professorbunbun Please call Boehringer Ingelheim @ 800-542-6257 option 4 to report adverse events or...
Source: Pharma Marketing Blog - April 21, 2011 Category: Pharma Commentators Tags: Boehringer Ingelheim social media adverse events Twitter Source Type: blogs
Experts Recommend Delaying Breastfeeding Until Vaccinations Have Taken EffectEmail this article to a colleague.
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Just when we thought the world could not get any more insane, it does! News came in today of a study entitled ‘Inhibitory Effect of Breast Milk on Infectivity of Live Oral Rotavirus Vaccines’ advising nursing mothers to delay breast-feeding until after vaccinations. According to the authors this is because breastfeeding lowers the vaccines efficiency!!!
A paper outlining the study was written by Sung-Sil Moon, PhD, Yuhuan Wang, MS, Andi L. Shane, MD, MPH, MSc, Trang Nguyen, PhD, Pratima Ray, PhD,§ Penelope Dennehy, MD, Luck Ju Baek, PhD, Umesh Parashar, MB BS, MPH,Roger I. Glass, MD, PhD, and Baoming Jiang, DV...
Source: vactruth.com - April 6, 2011 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Christina England Top Stories adverse Reactions Breast Feeding Source Type: blogs
Mother Jailed for Taking Vaccine Damaged Daughter Off the Drug RisperdalEmail this article to a colleague.
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A mother from Detroit was jailed this week for trying to protect herself and her daughter from the police and the CPS. Maryanne Godboldo’s problems began when her daughter aged 13 was given mandatory vaccinations. The shots were given to her daughter to enable her to begin public school. Shortly after the vaccines, Ms Godboldo noticed a sudden change in daughters behaviour. Her daughter became easily irritated, suffering severe mood swings with episodes of facial grimacing. Worried about her daughters strange and ‘uncharacteristic behaviour’ she asked the ‘The Children’s Centre’ for help...
Source: vactruth.com - April 1, 2011 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: ADD/ADHD Autism Christina England MMR Top Stories adverse reaction MMR vaccine vaccines Source Type: blogs
Antioxidants and Your HealthEmail this article to a colleague.
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Antioxidants are good for your health.
Or at least that is a popular claim.
An antioxidant is any molecule that slows down or prevents oxidation reactions. Originally, oxidation reactions were defined as chemical reactions with oxygen. More recently, oxidation reactions have been described as reactions in which an atom or molecule loses an electron.
Oxidation is a natural part of life. Excessively high antioxidant levels are detrimental to health. Some people have suggested that oxidation reactions contribute to heart disease, declines in cognitive abilities, and cancer.
“Vitamin C, vitamin E, and beta-carotene ha...
Source: World of Psychology - March 30, 2011 Category: Psychiatrists and Psychologists Authors: Jamie Hale Tags: Aging General Happiness Health-related Mental Health and Wellness Research adverse Effect Angina Anti Oxidants Antioxidant Levels Antioxidants Beta Carotene Biochemist C Vitamin Chemical Reactions Chest Pain Cognitive Abili Source Type: blogs
Adverse Event Reporting -- Pharma Puts Profits Before Patients. A Missed OpportunityEmail this article to a colleague.
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By now you should have heard that the Supreme Court recently ruled that investors can sue pharmaceutical companies for failing to disclose reports of adverse events even if the evidence is not "statistically significant" (see "Supreme Court Allows Investors to Sue Pharmacos Over AE Reporting Lapses").In a brief to the court, PhRMA (the US pharmaceutical trade association) said "A collection of adverse event reports that is not statistically significant does not permit a reasonable inference that a particular medicine actually caused the reported adverse event" (the brief is attached to the post cited above).But what is "st...
Source: Pharma Marketing Blog - March 25, 2011 Category: Pharma Commentators Tags: adverse events Source Type: blogs
Hide Side Effect Reports And Investors Can SueEmail this article to a colleague.
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After months of anticipation, the US Supreme Court yesterday ruled Matrixx Initiatives was incorrect to insist that only statistically significant adverse events are required to be reported to shareholders, and allowed investors to proceed with a long-simmering securities fraud claim. The move has significance for drugmakers and biotechs, which filed briefs supporting Matrixx over concerns adverse event disclosures can be easily misinterpreted and lead to more shareholder lawsuits.
Here’s the background: Matrixx Initiatives was sued for allegedly concealing side effect reports that its Zicam over-the-counter cold med...
Source: Pharmalot - March 23, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Event Reports adverse Events Anosmia FDA Matrixx Initiatives Sonia Sotomayor US Supreme Court Zicam Zinc Source Type: blogs
Doctors in UK Warned After a Catalogue of Vaccine Mix-UpsEmail this article to a colleague.
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Doctors across the UK have come under immense criticism after a survey revealed a catalogue of vaccine blunders. The Medical Defence Unit (MDU), who defends doctors accused of medical malpractice, carried out the survey. The results revealed that family doctors had been involved in vaccination blunders affecting 98 children and 10 adults over the last five years. These involved patients being given the wrong vaccine, the wrong dose of vaccine or were vaccinated without consent.
Amazingly, these errors included babies being administered the MMR shot ‘seven months’ before they should have been. In some instance...
Source: vactruth.com - February 23, 2011 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Christina England Top Stories Medical Negligence Vaccine Dangers adverse Reactions Source Type: blogs
Coronary Stent Thrombosis And Your Body ClockEmail this article to a colleague.
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Add coronary stent thrombosis to the list of cardiac events influenced by circadian rhythms, with more events occurring during the early morning hours and in a summertime window of late July and early August.
Coronary stent thrombosis joins several other adverse cardiac events that also follow a circadian pattern, such as stroke, unstable angina pectoris, acute myocardial infarction and sudden cardiac death, according to researcher published in JACC: Cardiovascular Interventions.
Most studies that addressed circadian variations in cardiovascular disease were done before the advent of stents, so, researcher from Mayo Clinic...
Source: Better Health - February 23, 2011 Category: Health Medicine and Bioethics Commentators Authors: RyanDuBosar Tags: Better Health Network Research ACP Internist adverse Cardiac Events Body Clock Cardiology Cardiovascular Disease Cardiovascular Risk Circadian Rhythm Coronary Stent Thrombosis Heart Health JACC Cardiovascular Interventions Mayo Cli Source Type: blogs
FDA Warns Sanofi For Failing To Report Side EffectsEmail this article to a colleague.
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You read it here first. In a harsh warning letter, the FDA has reprimanded Sanofi-Aventis for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill, and also did not report post-marketing studies or completed, unpublished clinical trials in NDA annual reports. The seven-page missive, which was dated January 28, comes after the agency reviewed Sanofi paperwork last May. And a separate letter dated February 9 notes that a Sanofi plant in Germany has problems with contamination.
When it came to r...
Source: Pharmalot - February 22, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Allegra D Apidra FDA FDA Warning Letter Lovenox Multaq Sanofi Aventis Side Effects Source Type: blogs
Quality and Safety in Health Care 2009 (Vol. 18 No. 1)Email this article to a colleague.
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This article reviews the impact of such errors and how this compromises patient care.
(Print subscription held at Fade Library)
Filed under: Health and Safety, Uncategorized Tagged: Adverse Drug Events, Errors
Source: Fade Library - February 11, 2011 Category: Medical Librarians Authors: bsnnbrou Tags: Health and Safety Uncategorized adverse Drug Events Errors Source Type: blogs
5 Steps to a More Resilient YouEmail this article to a colleague.
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Resiliency is what makes some people able to bounce back after a particularly traumatic or difficult time or stressor in one’s life, while others fall apart. It is a component of positive psychology, in that researchers try and figure out what makes resilient people different than others. And then seeks to help others learn some simple skills that may be able to help build resiliency in one’s own life.
There are no secret short-cuts to building greater resilience in your life. Most skills you can learn to help build resiliency are things that are going to take lots of time and lots of practice.
Practice is one...
Source: World of Psychology - January 30, 2011 Category: Psychiatrists and Psychologists Authors: John M Grohol PsyD Tags: Brain and Behavior General Happiness Mental Health and Wellness Personality Psychology Self-Esteem Stress 5 Steps adverse Events Adversity Blog Entry Christy Confidence Death Of A Parent Decades Divorce Doubt Failure Source Type: blogs
The Curious Case of Pfizer's Asbestos ClaimsEmail this article to a colleague.
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Here is a very strange and long-running story that raises some questions about how health care organizations are lead, but seems to have bee covered only in the business press.Pfizer Goes Into the Asbestos Business (in 1968), Faced Hundreds of Thousands of Lawsuits (in the 1980s), Promised to Settle (in 2004)Here is the background, per a 2004 report by the Associated Press, per Fox News:Pfizer Inc. (PFE) Friday said it has agreed to pay $430 million to settle all lawsuits against it alleging injury from insulation products made by a subsidiary.Pfizer and its Quigley Co. subsidiary were named, along with several other defen...
Source: Health Care Renewal - January 11, 2011 Category: Health Medicine and Bioethics Commentators Tags: Quigley Pfizer mission-hostile management legal settlements asbestos adverse effects Source Type: blogs
The Legal Battle Over Adverse Event DisclosureEmail this article to a colleague.
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Should drugmakers disclose all adverse event reports that may not show statistically significant evidence that a side effect is actually caused by a specific drug? The issue is now before the US Supreme Court involving a case brought by investors against Matrixx Initiatives, which was sued for allegedly concealing side effect reports that its Zicam over-the-counter cold med caused people to lose their sense of smell, known as anosmia (back story).
And in oral arguments yesterday, the case made by the lawyer for Matrixx may not have passed the smell test after he insisted Matrixx did not commit fraud when it failed to discl...
Source: Pharmalot - January 11, 2011 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Anosmia Elena Kagan Matrixx Initiatives Ruth Bader Ginsburg US Supreme Court Zicam Source Type: blogs
Will There Be More Chronically Ill and Developmentally-challenged Children in Pennsylvania?Email this article to a colleague.
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Back on May 28, 2010 the Commonwealth of Pennsylvania made changes to its immunization code to be effective August 1, 2011. What children in Pennsylvania will be required to have in vaccinations in order to attend school is taken directly from the code: (http://www.pacode.com/secure…)
23.83. Immunization requirements.
(a) Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school. Each school director, superintendent, principal, or other person in charge of a public, private, parochial or nonpublic school in this Commonwealth, including v...
Source: vactruth.com - January 5, 2011 Category: Health Medicine and Bioethics Commentators Authors: Catherine J. Frompovich Tags: Catherine Frompovich Top Stories Catherine J. Frompovich adverse Reactions immunization code Source Type: blogs
Barcoding Nets Both Safety and Lower CostsEmail this article to a colleague.
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Each year, adverse drug events cost an estimated $2 billion a year to treat. So, how can hospitals achieve the right medication, right dose, right patient, right time, and right route? According to the Agency for Healthcare Research and Quality, barcoding technology may be the answer.
Over the last few months, I’ve interviewed a long list of hospital CFOs with the goal of determining how they prioritize their capital spending. Several years ago when I made the same series of interviews, ROI was the determining factor. Now, as summed up by Debbie Schimerowski, CFO at Provena Covenant Medical Center, Urbana, IL, ...
Source: MD Buyline - December 8, 2010 Category: Technology Consultants Authors: james.x Tags: Value-Based Purchasing adverse drug event barcoding dosing safety Source Type: blogs
Safety in second place?Email this article to a colleague.
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The safety of newly marketed drugs is always provisional, based on the relatively limited population the drugs are used in prior to marketing. The number of subjects who take a drug in clinical trials is large enough to detect efficacy, but too small to detect rare, but serious, adverse events. In addition, the patients are [...]
Source: Black Triangle - November 30, 2010 Category: Psychiatrists and Psychologists Authors: Anthony Tags: Academia adverse drug reactions EBM Ethics Source Type: blogs
FDA Approves Vyvanse for TeensEmail this article to a colleague.
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In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo [...]. All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 mg and 70 mg dose groups were escalated by 20 mg per week until they achieved their assigned dose.
The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS). [...] All Vyvanse dose groups were superior to placebo in the primary efficacy outcome.
The safety of Vyvanse was also evaluated during the stu...
Source: World of Psychology - November 17, 2010 Category: Psychiatrists and Psychologists Authors: John M Grohol PsyD Tags: ADHD and ADD Children and Teens Disorders General Medications Treatment Adhd In Adolescents adverse Events Attention Deficit Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit Hyperactivity Disorder Adhd Dose Gr Source Type: blogs
Letter Alerts Obama to Dangers of HPV VaccinesEmail this article to a colleague.
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In an extraordinary move to prevent further HPV vaccine casualties, Marian Greene the Chairwomen and Co-Founder of the campaign and action group Truth about Gardasil (http://truthaboutgardasil.org/), has written an open letter to President Obama. Her letter urges the President to take time to research the HPV vaccines Gardasil and Cervarix and to read what is happening to the innocent young men and women of America. She opens her letter by saying:
“We come to you now to beg for your help. The lives of an entire generation of young women and now, men, are hanging in the balance.”
Greene strengthens her plea by alertin...
Source: vactruth.com - October 30, 2010 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Christina England Top Stories Barack Obama HPV Vaccine adverse Reactions Source Type: blogs
Multiple Deaths Linked to Childhood VaccinesEmail this article to a colleague.
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On 24th October 2010, the Sunday Times reported new evidence suggesting that forty children have died over the past seven years following a routine childhood vaccination. This was revealed after the Sunday Times sent a Freedom of Information (FOI) data request to the Medicines and Healthcare products Regulatory Authority (MHRA). The FOI data revealed that childhood vaccinations are suspected to have caused forty deaths, of leaving two young children with brain injuries and causing more than 1,500 other neurological reactions, including 11 cases of inflammation of the brain, 13 cases of epilepsy and a coma.
In the article &...
Source: vactruth.com - October 26, 2010 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Catherine Frompovich Death Top Stories Cervarix Christina England MHRA adverse Reactions Source Type: blogs
Actelion Pharma Failed To Report 3,500 DeathsEmail this article to a colleague.
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How is this for a difference of opinion? During an inspection of Actelion Pharmaceuticals offices in the summer of 2009, the FDA found the drugmaker was repeatedly failing to follow proper procedures for reporting adverse events and, as a result, about 3,500 patient deaths were never filed with the agency. Yes, about 3,500.
The reports referred to two different drugs - Tracleer and Ventavis – which are approved to treat various forms of pulmonary arterial hypertension. As the agency notes, however, this is a serious condition that often results in death. And so the FDA stresses there is no conclusion or implication that ...
Source: Pharmalot - October 7, 2010 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Actelion Pharmaceuticals adverse Events Tracleer Ventavis Source Type: blogs
Paracetamol: Recall bias and media biasEmail this article to a colleague.
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Just a short note. A couple of years ago there was a great deal of fuss about paracetamol and a possible link with asthma in children [Lancet]. The study reported on was a large retrospective study (205 487 children) involving surveying parents about their children’s previous paracetamol use and symptoms of asthma. There is an [...]
Source: Black Triangle - October 1, 2010 Category: Psychiatrists and Psychologists Authors: Anthony Tags: adverse drug reactions Media Pharmacovigilance Science Source Type: blogs
ObamaCare Prods Yet Another Insurer to Flee the MarketEmail this article to a colleague.
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By Michael F. CannonFirst, a dozen insurers said they would stop writing child-only health insurance policies. Now, according to the Wall Street Journal:
By forcing the exit of Principal Financial Group — which ran a profitable, $1.6 billion health insurance business — ObamaCare has now left 840,000 Americans to find another source of coverage.
According to The New York Times, other insurers may soon follow:
More insurers are likely to follow Principal’s lead, especially as they try to meet the new rules that require plans to spend at least 80 cents of every dollar they collect in premiums on the welfare ...
Source: Cato-at-liberty - October 1, 2010 Category: Health Medicine and Bioethics Commentators Authors: Michael F. Cannon Tags: Government and Politics Health, Welfare & Entitlements adverse selection Barack Obama child-only coverage health care reform health insurance exchanges health insurance mandates health insurance premiums Obamacare price controls prin Source Type: blogs
FDA: New Rules To Report Safety Info From TrialsEmail this article to a colleague.
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Responding to years of complaints that safety risks are being downplayed or ignored during the drug development process, the FDA has just issued a final rule for reporting safety information that crops up during clinical trials. This new rule requires certain safety info, which was was not required to be reported in the past, to be submitted within 15 days of when a drugmaker becomes aware of an issue.
To wit, drugmakers must report findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions that occur at a rate higher than expected and seriou...
Source: Pharmalot - September 28, 2010 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized adverse Events Clincal Trials Clinical Trials Council for International Organizations of Medical Sciences Drug Safety FDA International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals f Source Type: blogs
ObamaCare: Never Supported by a Majority, Now 10-Points behind with Likely VotersEmail this article to a colleague.
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By Michael F. CannonWith the addition of a poll by George Washington University and Politico — completed the day before ObamaCare started sending health insurance premiums higher, making coverage less accessible for children, and destroying health insurance innovations — Pollster.com shows that among likely voters, ObamaCare now suffers a 10-point popularity gap:
(As I’ve noted before, Pollster.com’s local-regression trend estimate will head off in a direction different from public opinion if the latest poll is a fluke. But these trajectories are consistent with Pollster.com’s trend estim...
Source: Cato-at-liberty - September 27, 2010 Category: Health Medicine and Bioethics Commentators Authors: Michael F. Cannon Tags: Government and Politics Health, Welfare & Entitlements adverse selection george washington university health care reform health insurance Lake/Tarrance Obamacare Politico Pollster.com public opinion Source Type: blogs
ObamaCare: Never Supported by a Majority, Now 10 Points behind with Likely VotersEmail this article to a colleague.
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By Michael F. CannonWith the addition of a poll by George Washington University and Politico — completed the day before ObamaCare started sending health insurance premiums higher, making coverage less accessible for children, and destroying health insurance innovations — Pollster.com shows that among likely voters, ObamaCare now suffers a 10-point popularity gap:
(As I’ve noted before, Pollster.com’s local-regression trend estimate will head off in a direction different from public opinion if the latest poll is a fluke. But these trajectories are consistent with Pollster.com’s trend estim...
Source: Cato-at-liberty - September 27, 2010 Category: Health Medicine and Bioethics Commentators Authors: Michael F. Cannon Tags: Government and Politics Health, Welfare & Entitlements adverse selection george washington university health care reform health insurance Lake/Tarrance Obamacare Politico Pollster.com public opinion Source Type: blogs
