In The News
Patients Stopping Tysabri Without Doctors' Knowledge?
According to a new study on disease-modifying MS drugs, patients who discontinued the use of Tysabri (natalizumab, Biogen-Idec) did not frequently cite "doctor's advice" as a reason. "Side effects too severe" and "Did not seem to work" were the top cited reasons for discontinuation. The report continues to say that patients reportedly stop Tysabri due to side effect severity less frequently than patient reportedly discontinue other disease modifying therapies for the same reason. The study is from the group “Patients Like Me,” a medical information web site.
Protein May Tell Tale of Inherited PD
Recent study results suggest a new genetic cause of inherited Parkinson's disease that researchers say may be related to the inability of brain cells to handle biological stress. While only a few families have been identified with this form of PD, authors of the report published in the September issue of the American Journal of Human Genetics say the study offers insight into how the EIF4G1 gene can lead to brain cell death, resulting in PD and associated neurodegenerative disorders. According to the Mayo Clinic, much is already known about the protein. For example, when a cell is undergoing stress the EIF4G1 protein helps initiate the production of other proteins to help the cell cope. Such stresses occur naturally as people age, and if a brain cell cannot adequately respond, it will die. This inability to adapt led to Parkinson's disease in the families studied, according to researchers.
AD Therapy Trial Progressing
Similar pathologic mechanisms underlie both Alzheimer's and Huntington's disease, according to a presentation at the World Congress on Huntington's Disease. The presentation by researchers for Prana Biotechnology included data on the company's planned PBT2 trial. In a Phase IIa trial of PBT2 in mild Alzheimer's Disease, cognitive executive function was significantly improved in patients. Also presented were details showing PBT2 was able to directly restore neurons critical to cognition in mouse models. It was demonstrated that PBT2 increased the number of spines on the branches (or dendrites) of neurons.
Statins Reduce Recurrence After Cryptogenic Stroke
Patients aged 15 to 49 who were treated with a statin following a stroke of unknown etiology were 77 percent less likely to have a new vascular event, according to a study published in the August 2 issue of Neurology. For their study, researchers analyzed a database of 215 patients (mean age: 39.1 years) with a first ischemic stroke and looked at their statin use. The composite vascular end point was any stroke, MI, or other arterial occlusive event, revascularization, or vascular death. Patients were followed for nine years.
Vitamin B12 Deficiency May Harm Thinking Skills
Low levels of vitamin B12 in older people may contribute to a loss of brain cells and development of cognitive problems, according to a study in the September 27 issue of Neurology. Researchers drew the blood of 121 people age 65 and older living in Chicago to measure levels of vitamin B12 and B12- related metabolites that can indicate a B12 deficiency. The participants also took tests measuring their memory and other cognitive skills. An average of four-and-a-half years later, MRI scans of the participants' brains were taken and revealed that high levels of four of five markers for vitamin B12 deficiency were associated with lower scores on the cognitive tests and smaller total brain volume. Foods that come from animals, including fish, milk, eggs and poultry, are usually sources of vitamin B12.
FDA Advertisement Guidelines Rarely Followed
New research suggests that advertising from the pharmaceutical industry may not comply with FDA guidelines. A study of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with FDA guidelines, and over half failed to quantify serious risks, including death (Public Library of Science One). Researchers performed a cross-sectional analysis of prescription pharmaceutical advertisements published in nine journals in November 2008. They evaluated adherence to FDA standards and the presence of content that is important for physicians to use when safely prescribing the drugs. Of the 192 advertisements for 82 unique products, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines. In addition, 57.8 percent of the advertisements did not quantify serious risks, 48.2 percent lacked verifiable references, and 28.9 percent failed to present adequate efficacy quantification.
Drug Reduces SEGA Tumor Size in Patients with TSC
Data from a Phase III trial presented at the International Tuberous Sclerosis Complex Research Conference showed that more than one-third of patients taking Afinitor (everolimus, Novartis) tablets experienced a 50 percent or greater reduction in the size of their subependymal giant cell astrocytomas (SEGA), non-cancerous brain tumors associated with tuberous sclerosis complex. This was the largest prospective clinical trial in this population. Afinitor is approved in the US to treat patients with SEGA associated with tuberous sclerosis who require therapeutic intervention but are not surgical candidates.
Site Aims to Increase Clinicians' Fibromyalgia Knowledge
To help healthcare professionals better understand fibromyalgia and be prepared to diagnose it, Pfizer has launched www.FibroKnowledge.com. The unbranded website provides comprehensive information about the disease state, diagnosis, and management through resources, such as tutorials on the current criteria for fibromyalgia diagnosis, including the 1990 and 2010 ACR criteria and a tender point video. There are also downloadable patient and healthcare provider tools available on the site. Expect site updates at least annually.
Pregnancy Protein in Women Could Indicate Alzheimer's
Researchers have discovered that older women destined to develop Alzheimer’s disease have high blood levels of a protein linked to pregnancy years before showing AD symptoms. Published in Journal of Proteome Research, the study looked for those proteins in blood samples of 86 people aged 60-90 years who participated in a larger study of aged-related brain changes. The “group found that significant elevations in pregnancy zone protein (PZP) occurred in women an average of four years before diagnosis of Alzheimer disease.” It has been known that PZP levels rise during pregnancy, but this was the first study to link the protein with Alzheimer's disease. The group “further discovered the apparent source of the PZP in the brain of these women, who were not pregnant: PZP was being produced in senile plaques, degenerated areas of the brain associated with Alzheimer disease.”
RRMS Drug Shows Promise in Phase IIb Study
The investigational compound daclizumab high-yield process (DAC HYP) significantly reduced annualized relapse rate among patients with MS by 54 percent in the 150mg dose arm (p< 0.0001) and 50 percent in the 300mg dose arm (p=0.0002) compared to placebo at one year, according to recently released data. DAC HYP met key secondary endpoints for the 150mg and 300mg arms, respectively, providing a highly statistically significant reduction in the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 (69 percent; 78 percent); in the number of new or newly enlarging T2 hyperintense lesions at one year (70 percent; 79 percent); and in the reduction in the proportion of patients who relapsed (55 percent; 51 percent). DAC HYP also showed a trend toward improvement in quality of life measures at one year.
Data come from the SELECT trial, a global, randomized, double-blind, placebo-controlled, one-year, dose-ranging study to determine the safety and efficacy of DAC HYP in 600 patients with RRMS. The study evaluated two doses of DAC HYP (150mg or 300mg administered every four weeks) and had a greater than 90 percent study completion rate in all treatment groups.
AMA Urges Supercommittee to Repeal SGR
Renewing its call for repeal of the Sustainable Growth Rate (SGR), the AMA this month sent a letter to the newly formed Joint Congressional Committee on Deficit Reduction, urging it to address the problem before a 30 percent cut in Medicare reimbursements takes effect January 1. AMA estimates it will cost nearly $300 billion to repeal the SGR now and that the cost will rise to $600 billion in five years.
“The Medicare physician payment system is broken, and we know that continued reliance on recent policies will increase the cost of fixing the problem,” said AMA President Peter W. Carmel, MD in a statement. The Association champions a threepronged approach to reforming the physician payment system:
1.) repealing the SGR,
2.) implementing a five-year period of stable Medicare physician payments, and
3.) developing a new payment system.
TBI May More Than Double Risk of Dementia
Older veterans who experienced traumatic brain injury showed a more than two-fold increase in the risk of developing dementia, according to new research presented at the Alzheimer's Association International Conference. Study authors reviewed medical records of 281,540 US veterans age 55 years and older who received care through the Veterans Health Administration and had at least one inpatient or outpatient visit during 1997-2000 and a follow-up during 2001-2007, and who did not have a dementia diagnosis at the start of the study.
The risk of dementia was 15.3 percent in those with a TBI diagnosis compared with 6.8 percent in those without a TBI diagnosis (p<0.001). The adjusted hazard ratio for incident dementia in those with any TBI diagnosis was 2.3 (95% confidence interval: 2.1, 2.5)—more than doubling the risk of developing dementia over seven years—and was significant for all TBI types. Approximately two percent of older veterans had a TBI diagnosis during the study period.
OnabotulinumtoxinA Approved for Incontinence
There’s another in the long list of indications for Botox (onabotulinumtoxinA, Allergan): for injection for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. FDA approved the new indication in August based on results of two Phase III clinical trials in which 200 units of Botox injected directly into the bladder muscle reduced urinary incontinence episodes by approximately 20 episodes per week at week six (19.9 and 19.6 episodes/week vs. 10.6 and 10.8 for the placebo group). Patients in the clinical trials were considered for retreatment with Botox when the clinical effect of their previous treatment wore off, which in the trials was up to 10 months (42-48 weeks for the 200U Botox group vs. 13-18 weeks for the placebo group).
Biosimilars Exclusivity Back on the Table
In his new budget proposal released in September, President Obama called on Congress to cut the 12- year exclusivity period on novel biologic therapies down to seven years—for a projected $3.5 billion in savings over 10 years. This is despite provisions in healthcare reform legislation that affirmed the 12-year exclusivity period. For more on biosimilars, read the article in our May/June edition, available online at PracticalNeurology.net.