Thickened arteries, heart disease, depression, suicide, and now, we can add bleeding of the brain to the long list of side effects of antidepressants. Though the risk is admittedly very small, researchers declared on Wednesday that selective serotonin reuptake inhibitors (SSRIs) may raise the risk of hemorrhagic strokes, which happen when the brain bleeds.
SSRIs include a wide variety of common antidepressents, including Prozac, Zoloft, Celexa, and Paxil. These drugs are also linked to an increased risk of stomach bleeding.
Platelets Can’t Clot, Hemorrhage
After analyzing 16 previous studies involving over 500,000 patients, researchers determined that SSRI users were 40 to 50 percent more likely to suffer bleeding of or around the brain. The researchers were not, however, able to collect other relevant data, like subjects’ smoking and drinking habits, diet, and whether they had diabetes. Their findings were published in the journal Neurology.
Although lead researcher Dr. Daniel G. Hackam of Western University in London, Ontario says that we “can’t infer cause and effect from this,” it isn’t exactly an unreasonable association. Blood cells (platelets) have difficulty clumping and clotting in the presence of SSRIs, causing the patient’s platelet function to stumble soon after taking SSRIs. This may be why patients experienced the greatest risk of hemorrhage within the first few months of taking the drugs.
People already at risk of brain hemorrhage would do well to stay away from SSRIs, Hackam added, as well as those on medications that reduce clotting like Coumadin or an aspirin-Plavix combination.
Psychiatrists and Financial Conflicts of Interest
It’s worth noting that Hackam also says that these drugs are, overall, “quite safe.” Perhaps he’s neglected to look at the Emory University School of Medicine’s findings that antidepressants thickened arteries 400 percent more than aging, which is the foremost factor of athersclerosis. Still other studies indicate that Cymbalta and other antidepressants cause 1 in 5 patients to feel worse than when administered placebos.
Why, then, are so many patients treated with powerful psychotactive drugs instead of a personalized combination of vitamin D, probiotis, diet, acupuncture, yoga, and other natural remedies? Perhaps because 70 percent of panel members to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders have financial ties to pharmaceutical companies.
Genetic modification of food has come under severe criticism from the scientific community as new health risks are being discovered. Do genetically modified vaccines carry any less risk? The study below outlines just a few of the unanswered questions about one of the genetically engineered vaccines currently in use, namely Gardasil®.
Dr. Sin Hang Lee of Milford Hospital recently published an article in The Journal of Inorganic Biochemistry entitled, Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®.
According to Dr. Lee’s research (sponsored by SaneVax Inc.), during the manufacture of Gardasil, Merck may have inadvertently created a new chemical compound composed of HPV L1 gene fragments chemically bound to the aluminum nanoparticles of the AAHS adjuvant used in the vaccine.
If this is true, the toxicity of this chemical has not been tested. No one knows what the potential health consequences the injection of this ‘ingredient’ may be.
A total of 16 samples of Gardasil® received from Australia, Bulgaria, France, India, New Zealand, Poland, Russia, Spain and the United States were found to contain fragments of HPV-18-L1 gene DNA which was readily detected in 15 of 16 samples tested, or HPV-11-L1 gene DNA, or a mixture of both. After submission of the manuscript, HPV-16-L1 gene fragments were also detected among these samples by a special protocol, Dr. Lee noted in his report.
Dr. Lee stated:
Although the U.S. Food and Drug Administration recently announced that Gardasil® indeed does contain recombinant HPV L1-specific DNA fragments, the physical condition(s) of these HPV DNA fragments in the final vaccine product has not been characterized.
Dr. Lee presented experimental evidence to assert that the binding mechanism between the HPV L1 gene DNA and the amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles in Gardasil® is of a chemical nature through ligand exchange of phosphate for hydroxyl, independent of the electrostatic forces. When aluminum (Al3+) and DNA interact, the binding site for Al3+ on the DNA chains is the phosphate groups on the DNA backbones.
For the average medical consumer, if the bond between the DNA and aluminum were electrostatic, it would be much like when you rub a balloon against your head until the static electricity builds up to the point where you can stick the balloon to a wall. As you may have noticed, given a short period of time, the balloon loses the static electric charge and falls off the wall. This is much the same as a vaccine in which the bond between the antigen and adjuvant is electrostatic. Once the vaccine is injected, the recipient’s normal pH level reduces the electrostatic attraction making the antigen and adjuvant separate from each other.
On the other hand, if the bond between the DNA and aluminum is chemical, it is more like taking a blob of super-glue and sticking the balloon to the wall. In this instance, no one knows how long the bond will remain intact.
In light of this substantial difference, Dr. Lee concluded:
The short-term and long-term impact of the residual fragments of HPV L1 gene DNA, or plasmid DNA, if chemically bound to the mineral aluminum of AAHS nanoparticles is largely unknown and warrants further investigation.
In Sept 2011, the SaneVax Team informed the FDA that HPV DNA fragments had been found possibly attached to the aluminum adjuvant in 100% of Gardasil samples tested by Dr. Sin Hang Lee of Milford Hospital.
The FDA response included the following statement with no references to back it up:
Recombinant technology has been used for many years to manufacture medicinal products. Gardasil does contain HPV L1-specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.
As you can clearly see, there is no mention whatsoever about these fragments possibly being attached to the aluminum adjuvant. The SaneVax Team as well as many eminent scientists and medical professionals around the world believe this ‘tiny’ detail should not be ignored.
If this ‘ingredient’ is indeed an ‘inevitable’ component of recombinant technology, medical consumers have a right to know when, for how long and under what circumstances it was tested for safety.
After an entire year of multiple communication attempts receiving no scientific documentation from the FDA that this ‘ingredient’ did not pose a health threat, the SaneVax Team sent another letter to the FDA Commissioner with one simple request.
This letter asked for copies of documents from the FDA showing:
To date, the FDA has made no effort to respond to this request. Do they have any documentation? If so, why do they not provide this critical information to medical consumers?
Surely, considering the fact that these fragments are an ‘inevitable’ component of recombinant technology, they have requested safety studies to determine any potential health impact. After all, they are responsible for the health and safety of medical consumers – aren’t they?
One more critical point:
Why did Merck not detect the residues of HPV-18-L1 gene DNA during the production of Gardasil®?
Dr. Lee offered the following explanation:
…all HPV-18 isolates can be classified into 3 subtypes based on alignments of the DNA sequences of the variants, (i.e. the European, the Asian-American and the African subtypes). In Europe, it has been reported that all of the HPV-18 isolates from patients are found to be of the European or Asian-American variants. In the U.S., 91% of the HPV-18 isolates from white women are reported to be of the European and Asian-American variants, and 64% of the HPV isolates from African American women belong to the African variant.
Since the prevalence of the African variants of HPV-18 among European patients is negligible, the Dutch researchers who originally developed the HPV INNO-LIPA kit naturally selected an HPV-18 probe targeting a homologous sequence shared by all European and Asian-American HPV-18 variants for the testing.
However, the HPV-18 L1 protein-coding gene chosen by the manufacturer for Gardasil® closely related to an African subtype. Failure to detect a target sequence of an African variant HPV-18 DNA in the vaccine Gardasil® with a hybridization probe specifically designed for the European and Asian-American DNA variants may simply reflect the diversity of the L1 protein amino acid sequences within the genotype of HPV-18.
For medical consumers, this brings additional questions. Has Gardasil® been tested for efficacy against all three HPV-18 variants?
Are families in the United States and Europe putting their children at risk of unknown health consequences resulting from the injection of a new chemical with untested toxicity in order to obtain ‘protection’ against only one type of oncogenic HPV?
The time has come for medical consumers to hold their national health ‘authorities’ accountable. These questions must be answered before any more children become ‘one less.’
(Note: Dr. Lee’s study was commissioned and sponsored by SaneVax Inc. for a future payment not to exceed one U.S. dollar.)
This press release was submitted to Activist Post, and first appeared at SaneVax.org Here:
A new report on ADHD has emerged, but instead of being a dry statistical evaluation of some clinical endpoint, it’s a lively representation of what children with ADHD themselves have to say about their condition. As the Telegraph reports:
Many are concerned that Ritalin and similar drugs, which aid concentration in those with Attention Deficit Hyperactivity Disorder, are chemical straightjackets that prevent children from taking full responsibility for themselves.
But Dr Ilina Singh of King’s College London said she and colleagues found no evidence this was the case, after interviewing scores of children on the drug.
Instead she found children commonly thought it benefited them, by helping clear their heads to make the right decision. It did not “make the decision for them”, she insisted.
One perspective that is often AWOL from stories about neurobiological conditions is the view from those who have the condition. I’ve called before for including autistic voices in articles about autism, and that applies for ADHD, as well. That’s why I was glad to see this report from Ilina Singh, a bioethicist at King’s College London, and colleagues relaying what children with ADHD have to say about it and about the medications they take for it. The report [very large PDF], which has what I can only describe as a festive format, is not peer reviewed but does detail the inner lives of 151 UK and US children with ADHD.
With as many as 14,000 people exposed to tainted steroid injections, resulting in more than 200 infections and 15 deaths, and more expected in the coming weeks, the drug delivery system is once again coming under scrutiny and has been threatened with loss of confidence.
In the shameful steroid contamination scandal now continuing to evolve, the New England Compounding Center appears to have exploited an astonishing loophole. Compounding pharmacies are supposed to mix custom combinations of drugs from already manufactured materials when ordered by a doctor. Some compounding pharmacies will pre-mix certain recipes. They call it “anticipatory compounding.” In the case of the fungus-tainted steroid, the New England Compounding Center mixed a batch of 17,000 doses. Massachusetts Gov. Deval Patrick has said that the company was operating outside the limits of its state license.
“What they were doing instead is making big batches and selling them out of state as a manufacturer would,” Patrick said Wednesday at a news conference.
A recent Washington Post piece clearly illustrates the complete lack of integrity and responsibility among our nation’s regulatory agencies when it comes to protecting the public against companies like NECC, which appears to have been actively flouting the law for years without consequence. And whenever a tragedy of the magnitude observed in the meningitis outbreak occurs as a result of such regulatory failure, the agencies responsible immediately begin complaining about how they did not have enough resources, enough manpower, enough legal authority — whichever excuse will shift blame the fastest is typically the one that is used.
The U.S. Food and Drug Administration (FDA), for instance, which should have been actively addressing the problems it first discovered back in 2006 at the NECC facility, instead chose to do nothing. And now that at least 15 people have died and another 205 infected with deadly fungal meningitis, the FDA is whining like a baby about how it needs more power and authority to do its job. This is utter nonsense, of course, as the FDA already has more than enough power to address the types of problems it found at NECC.
“They have all the regulatory authority they need,” said Peter Barton Hutt, a former FDAchief counsel, in response to FDA complaints that a new “regulatory scheme” is needed to control these types of risks. “[The agency] couldn’t ask for any more. What they need are better resources and better coordination.”
Published: 16 October, 2012, 01:24
The meningitis outbreak ravaging the US may not end up under control anytime soon: now health officials have found two new drugs that they think may have exposed even more patients to the potentially lethal virus.
The New England Compounding Center (NECC) in Massachusetts has already recalled all of its products from store shelves after tainted vaccines produced in their labs were linked to a recent meningitis outbreak that has so far claimed 15 deaths across the US and infected around 14,000 patients. Now authorities fear that two other drugs manufactured by NECC could be tarnished, opening up even more Americans to possible infection.
The Food and Drug Administration (FDA) is now expediting their outreach to physicians and patients across the country who could have come into contact with two new drugs being linked to the epidemic.
“At this point in FDA’s investigation, the sterility of any injectable drugs… and cardioplegic solutions” produced by NECC are “of significant concern,” the FDA says in a statement this week.
Previously a steroid injection used for back pain produced by NECC, methylprednisolone acetate, was believed to be the only culprit behind the outbreak. Now, however, the FDA believes doses of triamcinolone acetonide and cardioplegic solution could be causing causes as well. Those drugs are often administered to patients undergoing organ transplants or eye surgery, Fox News reports.
So far the FDA has refrained from putting a number on their estimate of how many additional patients may have been exposed to the tainted drugs, and for now cannot confirm for certain if the two new drugs are to blame. In the meantime, though, they are cautioning all persons who have received injectable drugs produced by the New England factory to investigate with their physician.
Just last week, Dr. Todd Weber of the Centers for Disease Control told USA Today, “We are not out of the woods yet” in terms of tackling the epidemic.
The meningitis outbreak caused by contaminated steroids has killed 15 people and infected 231 as of Tuesday, according to the Centers for Disease Control and Prevention. And the situation is not improving.
“We’re nowhere near the end of this problem,” says Vanderbilt University Medical Center expert Dr. William Schaffner. “We will see more patients reporting in ill and we’ll have to treat many more going forward.”
14,000 People at Risk
Earlier this month, the Food and Drug Administration found fungus in sealed vials of a steroid manufactured by the New England Compounding Center (NECC) based in Massachusetts. The spinal steroids are typically used to relieve back pain, but the fungal contamination has caused non-contagious fungal meningitis. The condition affects the protective membranes around the brain and spinal cord, causing headache, fever, nausea, stiffness of the neck, confusion, dizziness, and aversion to light.
Of the 23 states that ordered medications from the compounding facility in question, only 8 have not reported at least one case of fungal meningitis. Authorities say that almost 14,000 people received injections of the steroid and may develop the potentially deadly condition.
Other Drugs Possibly Contaminated
To make matters worse, the FDA is investigating other drugs that may have been contaminated at the facility. Two patients administered different steroids than the one aforementioned have reported possible fungal meningitis infection—one injected during open heart surgery, and the other injected with triamcinolone, yet another steroid.
FDA official Janet Woodcock reassures the public that “there’s a good probability they are not linked,” but it isn’t helping NECC’s reputation. The facility is already being sued by numerous victims, and a congressman is calling for an even deeper investigation.
NECC in Hot Water
NECC, like all compounding facilities, produces drugs based on a single patient’s individual needs as described by a physician. Reuters uncovered evidence, however, that NECC broke state law when they failed to request individual patient prescriptions along with bulk orders from physicians.
Massachusetts Democratic congressman Edward Markey referenced this breach when he demanded for a probe of NECC, this time regarding potentially addictive, “controlled” drugs.
“This is a matter that I believe requires further investigation by the [Drug Enforcement Agency] to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances.”
If you have received a steroid injection and experience symptoms of fungal meningitis, seek medical help immediately. Dr. Schaffner says the symptoms are rarely mild and patients have a greater chance of survival if treated early.
Corporate greed trumps noble intentions yet again in the world of Big Pharma. Sanofi, the world’s fourth-largest pharmaceutical company, recently withdrew the leukemia drug Alemtuzumab after 20 years of prescribing it, off label, to treat multiple sclerosis patients. Sanofi and subsidiary Genzyme cite intentions to apply for appropriate licensing—but before you applaud the companies for following regulations, keep in mind that they intend to rebrand and raise the cost of Alemtuzumab—by 15 to 20 times.
Prescribing drugs according to a physician’s instinct (or pocketbook) rather than according to the drug’s license is known as “off label” use. While perhaps deservedly frowned upon, neurologists began prescribing Alemtuzumab off label to MS sufferers after the New England Journal of Medicine published study results favoring alemtuzumab over another drug in the treatment of MS. Alemtuzumab also costs less, requiring two courses over two years.
Genzyme, however, will change that by rebranding alemtuzumab as Lemtrada and raising prices, halting supplies in the meantime because “any adverse event outside a clinical trial…may complicate the regulatory process.
“Shows Little Regard for Patients”
Many neurologists have written letters of protest to the UK’s Health Secretary, Jeremy Hunt. According to professors Neil Scolding, Neil Robertson, and John Zajicek, UK patients with MS in the middle of treatment with alemtuzumab will “not be able to get their vital second course.” New patients would “miss their window of therapeutic opportunity,” as well.
Regarding the rebranding and price increase, the professors add,
It shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation.
Genzyme’s parent company, Sanofi, is certainly not short in profits, which last year amounted up to nearly €6 billion (roughly $7.8 billion).
Sanofi isn’t the first pharmaceutical giant to use drugs’ supposed efficacy to make unwarranted profits to the detriment of patients, either. GlaxoSmithKline paid celebrity doctors like Dr. Drew to push harmful antidepressants for off label uses (including unfounded claims of weight management and erectile dysfunction), and Pfizer is undergoing clinical trials of Xalkori to treat a rare form of lung cancer—for over $100,000 per patient. Similarly to the initial case, KV pharmaceutical company offers a drug known as Makena which is meant to reduce the risk for premature births. But good luck using it if you’re interested, as the company recently raised the price from $10 to $1,500 per dose.
Earlier this year, however, Canadian and British scientists found that vitamin D—whether acquired through sunshine or supplements—may help prevent MS by affecting the gene that raises risk of MS development.
October 17, 2012
Criminal investigators from the Food and Drug Administration were at the New England Compounding Center in Framingham, Mass., on Tuesday, officials said, in the first public indication that the federal government was preparing a case against the company linked to a deadly meningitis outbreak.
Federal and state officials have said they believe that contaminated pain medicine from New England Compounding had caused the deaths of 16 people and sickened more than 200. And while investigators from the F.D.A’s regulatory section have been in and out of the company’s offices since early October, Tuesday appeared to have been the first time criminal investigators were on site.
The F.D.A. is a regulatory agency, but embedded within it is a section devoted to criminal prosecutions. The agents at the company Tuesday were from that section.
October 13, 2012
Medical officials in England are speaking out about a growing and disturbing trend—debilitating headaches that are actually being caused by the drugs meant to stop them. According to the Daily Mail, as many as one-in-50 people in England have regular headaches that are actually triggered by pain medication.
Experts say too many people are getting on a vicious cycle—popping pills at the first sign of a headache and then experiencing more headaches from the pills themselves, sending them back to the pill bottle again and again. This is sad news for individuals partaking in the pill ingestion, as both prescription and non-prescriptions painkillers have been linked to numerous negative health effects. In fact, there have even been more deaths than painkillers than illegal drugs like cocaine and heroin combined.
Health watchdog NICE says that doctors might not be prescribing the pain medications properly or diagnosing the condition they call medication overuse headache. This is where the medication actually makes the brain more sensitive to pain and more prone to headaches.
So, a reoccurring tension headache or migraine treated with a pain pill could create more and more of the same headaches. All of this is happening while natural home remedies for headaches rest without being noted. And these treatments aren’t accompanied by the nasty side-effects that medications induce.
NICE says many of these headache sufferers could find relief from a different class of drugs like triptans, inhaling oxygen, or possibly even acupuncture. Another class of drugs doesn’t sound like a great solutions, but acupuncture could work. After all, research involving 18,000 people has shown that acupuncture for pain is truly effective.
They say some patients have become so overcome with pain they are asking their doctors to perform brain scans or other diagnostics in order to rule out things like brain tumors, not realizing their source of relief is actually the source of their pain.
A study published in the Cleveland Clinic Journal of Medicine defines medication overuse headache as a headache that occurs on 15 or more days per month for at least 3 consecutive months. They say it is most common when the patient uses butalbital or opiods for pain relief.
They recommend relaxation therapy, biofeedback, and cognitive behavioral therapy as potential alternatives and as a method to wean the patient off of the medications causing the pain.
Another option is to use herbal remedies for headaches such as lemongrass. Lemongrass, when made into a tea, has been shown to have numerous benefits, with headache relief being one of the most prominent. (For instructions on making your own lemongrass tea, click the link just above).
Headache sufferers can also find relief from drinking more water, and using essential oils like peppermint and lavender. Massage and other methods of relaxation can further reduce muscle tension that leads to headaches.
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