FDA Attempts To Shutter A Compounding Pharmacy For Good
In the latest ‘get tough’ move by the FDA against wayward compounding pharmacies, the agency has filed a lawsuit seeking a permanent injunction against a New Jersey pharmacy called Med Prep Consulting for a host of violations associated with distributing contaminated medications.
The move comes three months after Med Prep recalled all of its nearly 100 products after a Connecticut hospital noticed "visible particulate contaminants" that turned out to be mold in 50 millimeter bags of an intravenous solution (back story). New Jersey officials then took legal action to revoke its permit and license (see this).
In seeking ...
Source: Pharmalot - June 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Dangerous Vaccines Found to Cause Symptoms of Shaken Baby Syndrome
Conclusion
There are many papers that state that children have died within weeks, if not days, of receiving multiple vaccinations. Many of these children have been misdiagnosed as suffering from Shaken Baby Syndrome.
Shaken Baby Syndrome is a hypothesis — a theory — as it has never been conclusively proven that a baby has been shaken to death. I have yet to find concrete evidence of someone physically shaking a baby so hard that the baby has later died solely from the “triad” of injuries. There are, however, a number of biomechanical studies stating that it is not physically possible to manually sha...
Source: vactruth.com - June 22, 2013 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Christina England Top Stories encephalitis Meningitis Reid Technique Shaken Baby Syndrome (SBS) vaccine injury Vaccine Safety Source Type: blogs
Top stories in health and medicine, June 19, 2013
Brought to you by MedPage Today.
1. Organ Donors Will Sign Up on Facebook. Despite years of media and public service campaigns appealing for organ donations, donor rates remained static while demand increased — until Facebook.
2. MRI May Spot Meningitis from Tainted Steroids. A screening MRI may provide early warning of spinal or paraspinal meningitis in patients who received contaminated steroid injections.
3. Red Meat Hikes Diabetes Risk. Eating more beef, pork, and lamb may raise diabetes risk, whereas reducing intake appears to trim risk.
Your patients are rating you online: How to respond. Manage your online re...
Source: Kevin, M.D. - Medical Weblog - June 19, 2013 Category: Family Physicians Tags: News Diabetes Endocrinology Facebook Infectious disease Source Type: blogs
Compounding Problems: Big Insurer Ends Coverage For Compounded Meds
In the latest fallout from the compounding pharmacy scandal, Harvard Pilgrim Health Care, which is one of the largest insurers in New England, has decided to end coverage of specialty medications due to safety and cost concerns, The Boston Globe writes. Not surprisingly, the move is angering pharmacists and patient advocates.
The decision follows a nationwide outbreak that began last fall of fungal meningitis, which has, so far, led to 748 cases, including 58 deaths, and has been called the worst public health crisis in the US in decades (see the numbers here). The episode has led to stepped up efforts by the FDA and offic...
Source: Pharmalot - June 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
A Premature Death? KV Pharma And Makena Make An Unexpected Comeback
Ever since the scandal erupted over compounding pharmacies and a national outbreak of fungal meningitis, KV Pharmaceuticals has been telling the FDA ‘we told you so.’ Now, the drugmaker, which landed in bankruptcy after a pricing controversy over its Makena treatment for premature births caused a ruckus and dramatically slashed sales, is finally experiencing a degree of vindication.
For months, KV has been complaining about the quality of some compounded versions of Makena (back story). Specifically, KV has pointed to the troubles at the New England Compounding Center, which was blamed for 741 cases of meningitis, incl...
Source: Pharmalot - June 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Now, A Tennessee Compounder Is Tied To Serious Infections
Less than a month after Tennessee adopted a law that eased restrictions on compounding pharmacies, the FDA is investigating seven cases in which patients suffered adverse events after being injected with what are apparently contaminated medications that were compounded by a specialty pharmacy.
As a result, Main Street Family Pharmacy is recalling all of its sterile products, most of which are injectable drugs, although the medications traced to the adverse events contain methylprednisolone acetate, which is the same drug that caused the deadly outbreak last year of fungal meningitis (see this).
That outbreak, which has so ...
Source: Pharmalot - May 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
NICE fever guidelines for kids
Fever is the most common presentation to Paeds ED and it can be difficult to identify a focus. This causes us (me anyway) a great deal of concern. After 10 years in paediatrics it still is the one thing weighing at the back of my mind – how to identify the child with the life-threatening bacterial infection amongst all the viral illnesses. NICE have updated their guidance in May 2013.
Often, they make it easy for us. Knowing how to recognise a sick child comes pretty early on in your paediatric experience. It’s the ones that don’t look desperately sick that are tricky. Let’s be honest, at 4am, every hot...
Source: Life in the Fast Lane - May 28, 2013 Category: Emergency Medicine Doctors Authors: Tessa Davis Tags: Emergency Medicine Featured Pediatrics fever Guidelines NICE NICE guidelines paediatric Source Type: blogs
NICE fever guidelines for kids
Fever is the most common presentation to Paeds ED and it can be difficult to identify a focus. This causes us (me anyway) a great deal of concern. After 10 years in paediatrics it still is the one thing weighing at the back of my mind – how to identify the child with the life-threatening bacterial infection amongst all the viral illnesses. NICE have updated their guidance in May 2013.
Often, they make it easy for us. Knowing how to recognise a sick child comes pretty early on in your paediatric experience. It’s the ones that don’t look desperately sick that are tricky. Let’s be honest, at 4am, every hot...
Source: Life in the Fast Lane - May 28, 2013 Category: Emergency Medicine Doctors Authors: Tessa Davis Tags: Emergency Medicine Featured Pediatrics fever Guidelines NICE NICE guidelines paediatric Source Type: blogs
Ophthalmologists Balk At Senate Compounding Bill Over Avastin Restrictions
As the US Senate considers legislation to toughen oversight of compounding pharmacies, one group of physicians is lobbying the Senate to create an exception for biologics. The American Academy of Ophthalmology is concerned about a provision in the Senate bill that requires patients to have specific prescriptions for each medicine that is ordered from a compounding pharmacy (here is the bill).
The language is designed to prevent compounding pharmacies from expanding into large-scale production, which is what the New England Compounding Center had been doing before producing medicines that led to a nationwide outbreak of fun...
Source: Pharmalot - May 22, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
When All You Have Is A Hammer: The Problem With Outsourcing Primary Care To Non Physicians
Image Credit: Dan Page, Boston Globe
What is the US going to do about our current and future primary care physician shortage? Many believe that the solution is to expand the scope of nursing practice, and license non-physicians (such as naturopaths) to practice medicine. In the face of scarcity, 17 states have licensed naturopaths to provide primary care and nurse-led, in-store pharmacy clinics are gaining popularity.
Studies have shown that nurse practitioners are as capable as physicians at treating common primary care complaints such as strep throat and headache. What studies have NOT shown is that nurse practitioners r...
Source: Better Health - May 19, 2013 Category: Health Medicine and Bioethics Commentators Authors: Dr. Val Jones Tags: Opinion AMA Care Quality Differential Diagnosis Minute Clinic Naturopaths Nurse Practitioners Primary Care Risks What's The Harm Source Type: blogs
Revealed Government Documents Show Vaccine Injured Children in Small African Village Used Like Lab Rats
Conclusion
The parents’ requests are simple and the same as any other parent left in this impossible situation. They feel deserted and betrayed by the Chadian government, who have left their children to die, while at the same time announcing the vaccination program to be a success. All the parents are very angry and are pleading with the world to help. They state they need lawyers, doctors, medication and above all, support.
This whole debacle has been a coverup from the very beginning. One of the children’s relatives has told me that there has never been a case of meningitis in this part of Africa. So, why vaccina...
Source: vactruth.com - May 19, 2013 Category: Health Medicine and Bioethics Commentators Authors: Christina England Tags: Christina England Top Stories Adverse Reaction MenAfriVac Meningitis Vaccine Project (MVP) PATH United Nations Children’s Fund (UNICEF) World Health Organization (WHO) Source Type: blogs
A Step Back in Time
By Nathan Ramsey, MD
I traveled to Ghana, West Africa, during the fall of 2010 with the sidHARTe program (www.sidharte.org) sponsored by the Joseph L. Mailman School of Public Health of Columbia University. I spent six weeks at a district hospital participating in an educational program, the goal of which was to develop a curriculum and to focus on training midlevel providers in the basics of emergency medicine. Emergency medicine is a developing specialty in Ghana. Most emergency care is provided in ill-equipped casualty units in district hospitals. The units are rarely staffed by physicians and the first-line provider...
Source: Going Global - May 16, 2013 Category: Emergency Medicine Tags: Blog Posts Source Type: blogs
A Step Back in Time
By Nathan Ramsey, MD
I traveled to Ghana, West Africa, during the fall of 2010 with the sidHARTe program (www.sidharte.org) sponsored by the Joseph L. Mailman School of Public Health of Columbia University. I spent six weeks at a district hospital participating in an educational program, the goal of which was to develop a curriculum and to focus on training midlevel providers in the basics of emergency medicine. Emergency medicine is a developing specialty in Ghana. Most emergency care is provided in ill-equipped casualty units in district hospitals. The units are rarely staffed by physicians and the first-line provid...
Source: Going Global - May 16, 2013 Category: Emergency Medicine Tags: Blog Posts Source Type: blogs
New Laser System to Help Surgeons Drill Through Skull with Increased Safety
Brain injuries and strokes can sometime require surgeons to relieve pressure on the brain by drilling burr holes through the skull using a trephine. The device is straight out of the good old days of medicine when surgical tools and torture implements were made by the same manufacturers. Yet, while even dentistry has moved on, performing burr hole craniotomies is still very much a manual cranking operation prone to causing injury and even leading to meningitis.Researchers at Fraunhofer Institutes for Photonic Microsystems, Laser Technology, and Integrated Circuits have developed a new laser system that may soon replace th...
Source: Medgadget - May 15, 2013 Category: Technology Consultants Authors: Editors Tags: in the news... Source Type: blogs
