Major Advance in Glioblastoma Treatment
In 2015, CBS News 60 Minutes featured a story about research emanating from Duke University Medical Center showing complete responses in terminal glioblastoma patients who were administered a re-engineered polio virus directly into their brain tumor. The re-engineered virus prompted a powerful immune response against the viral-infected cancer cells that in some patients appear to eradicate their glioblastoma.
Immunotherapy: Using the Immune System to Treat Cancer
Scanning electron micrograph of a human T lymphocyte (also called a T cell) from the immune system of a healthy donor. Source: National Institute of Allergy and Infectious Diseases (NIAID). The immune system’s natural capacity to detect and destroy abnormal cells may prevent the development of many cancers. However, some cancers are able to avoid […]
FDA and Intravenous Vitamin C Cancer Therapy
If FDA officials actually listened to patients, they wouldn’t be trying to cut off the use of intravenous ascorbic acid (IAA) as a cancer-fighter..
10,000 IU/day Vitamin D Needed for Therapeutic Benefit; Vitamin K Benefits
According to this article in the American Journal of Clinical Nutrition, pregnant women have an even greater need for Vitamin D supplements than non-pregnant women. http://www.ajcn.org/content/79/5/717.full If she were my wife, I would have her on two Vitamin D 5000 IU gel caps — one in the morning and one in the evening 12 hours later. Vitamin D works slowly.
Checklist of Treatments for Alzheimer’s Disease Part 1 of 3
For approximately ten years, I cared for a parent with slowly advancing Alzheimer’s disease. Contrary to all of the horror stories portrayed in the national media, I have found that the burden of caring for an Alzheimer’s sufferer is less onerous than I originally expected. The primary reason that my burden was lightened is that […]
“It doesn’t make sense to hire smart people and then tell them what to do; we hire smart people so they can tell us what to do.” — Steve Jobs
Let’s explore the green algae known as Chlorella. The name is taken from the Greek chloros, which means green, and the Latin suffix ella, meaning small. This supplement is growing in popularity in the US, and in Japan it is already one of the most widely used supplements. In fact, chlorella use in Japan is more common than our use of vitamin C in the US. So, why is it so popular there?
This algae was first heavily studied as a possible mass food source to address food shortage concerns after World War II. It was believed that chlorella could serve as a potential source of food and energy because its photosynthetic efficiency can, in theory, reach 8%, comparable with other highly efficient crops such as sugar cane. It is also considered an attractive potential food source because it is high in protein and other essential nutrients; when dried, it is about 60% easily digested and utilized protein, 9% fat, 22% carbohydrate, 5% fiber, and 9% minerals, vitamins, and chlorophyll.
Testosterone normalization associated with lower risk of heart attack, stroke and mortality from all causes over follow-up
Tuesday, August 11, 2015. On August 5, 2015, an article published in European Heart Journal reported that normalization of low testosterone levels through the use of testosterone replacement therapy (TRT) was associated with a significant decrease in the risk of myocardial infarction (MI, or heart attack), stroke and premature mortality from all causes in a large group of male veterans.
The study included older men who received their medical care at the Veterans Health Administration from December 1999 to May 2014. Subjects were limited to men without a history of heart attack or ischemic stroke whose initial total testosterone levels were below normal laboratory reference ranges. These included 43,931 patients who had normal total testosterone levels after receiving testosterone replacement therapy, 25,701 men who continued to have subnormal testosterone after therapy, and 13,378 patients with low testosterone who were untreated.
Over follow-up, the group with normalized testosterone levels had 47% fewer deaths than men whose hormone levels failed to normalize after testosterone replacement and 56% fewer deaths than those who did not receive TRT. When myocardial infarction was evaluated, men whose testosterone levels were normalized had an 18% lower risk than those whose levels failed to normalize and a 24% lower risk than untreated men. Ischemic stroke risk in normalized men was 30% lower than those who failed to attain normal testosterone levels and 36% lower than those who did not receive the hormone. As potential protective mechanisms, the authors cite testosterone’s beneficial effects on adipose tissue, insulin sensitivity and lipids, as well as its anti-inflammatory and anticoagulant effects.
“In this study of men, without previous history MI or stroke, with low testosterone levels, normalization of testosterone levels using TRT is associated with lower mortality, fewer MIs, and strokes,” corresponding author Rajat S. Barua, MD, concluded. “This is the first study to demonstrate that significant benefit is observed only if the dose is adequate to normalize the testosterone levels.”
Testosterone replacement enhances aerobic capacity
The joint meeting of the International Society of Endocrinology and the Endocrine Society was the site of a presentation on June 22 concerning findings obtained from a clinical trial of men with limited mobility which revealed improved aerobic capacity among those treated with testosterone.
The current study evaluated data from 64 men with low testosterone enrolled in the Testosterone in Older Men with Mobility Limitation Trial. Participants in the trial received 10 milligrams testosterone in gel form or a placebo gel daily for six months. Cycle exercise tests conducted at the beginning and end of the treatment period provided measures of aerobic function, including peak oxygen uptake and gas exchange lactate threshold.
At the trial’s conclusion, men who received a placebo saw a reduction in peak oxygen uptake, while those treated with testosterone experienced improvement.
“We believe this is the first report of enhanced endurance performance as a result of testosterone therapy in men who have difficulty performing some physical tasks but are otherwise healthy,” announced lead author Thomas W. Storer, PhD, who is the Director of the Exercise Physiology Laboratory at Brigham and Women’s Hospital in Boston. “At least in the short term, testosterone therapy may lessen the rate of decline of an important marker of physical fitness in older men with low testosterone.”
“These findings are potentially relevant to older men who have experienced the age-related decline in endurance capacity that may be due in part to low testosterone,” he added. “If proven safe over the long-term, restoring testosterone to normal levels may improve an important measure of physical performance and enhance their quality of life.”
- Provide expertise/strategic leadership of key initiatives within the US General Medicine and Health Economics and Outcomes Research (HEOR) functions
- Responsible to provide direction, oversight and coordination of complex activities within HEOR portfolio(s) and functions including budget & strategic resource management support to VP/Heads within US Medical teams
- Partner with HEOR Head and provide project management & operational expertise
- Drive annual strategic planning process across the specific portfolio including coordination of communications across the teams
- Responsible to lead budget planning & management including strategic resource management recommendations in partnership with Head of HEOR
- Accountable for summary of all HEOR spend changes & assumptions to clearly communicate budget forecasted vs. actual and actions/decisions required with defined accountabilities for budget owners
- Challenge budget owners on assumptions & ensures documentation
- Requires rationale and appropriate level of detail from all budget owners to assess implications and decisions required on a monthly basis
- Responsible for maintaining external spend and forecast accuracy within 5% of budget on a quarterly basis
- Facilitates monthly pre-alignment meetings and Medical Budget Alignment meeting & coordinates with Project Budget Managers role to facilitate data accuracy within tracker tool & meeting minutes
- Drive and facilitate 2016 Tactical Plan completion in preparation for 2016 (seasonalization of tactics by month) ~Oct 2016
- Able to facilitate and work amongst entire HEOR team and amongst all therapeutic areas (CV/Resp, Imm/Derm, NS, Early Development, and HEOR non-brand) 5 trackers with 4 Project Budget Managers and consolidate this information into a summary for the Budget Alignment meetings
- Able to understand and track HEOR contracts and HEOR tactics (analyses, models, data analytics, etc.) ongoing (working with Strategic Sourcing and tactic owners)
- Work with tactic owners to consolidate business needs for new tactics for Ethics and Compliance submission Comparative Effectiveness Review (CER) responses project management of this process and coordination between internal stakeholders to consolidate response and provide in the time requested
- Project management support for complex projects facilitate internal and external stakeholders communications and provide high level timeline tracking and budget management
- Bachelor Degree REQUIRED; Advanced degree preferred (MS, MPA, MPH, MBA, MD, PhD, or Pharm.D)
- Pharmaceutical industry or relevant healthcare experience
- Project management as key component of role
- Excellent, proactive stakeholder management skills
- Excellent interpersonal communication skills and customer service orientation
- Strong cross-functional collaboration skills
- Demonstrated ability in strategic thinking and strategic planning, resource management and budget management
Understanding of the FDA, OIG, HIPAA and other guidelines relevant to the pharmaceutical industry
Michael has worked on global value dossiers (GVD) for pipeline and marketed pharmaceuticals as well as medical devices in the cardiac surgery and wound healing space. These value dossiers reflect detailed assessment of payer reimbursement levels, value propositions in terms of net savings to the payers, and competitive market assessments. Normally, Michael is tasked as the Project Manager for the GVD and coordinates workflows from regulatory, clinical affairs, scientific and engineering, and commercial teams. One reason he is particularly well-suited to manage cross-functional GVD development teams is that he understands how to construct persuasive value propositions as a Ph.D. economist, he understands the legal and regulatory aspects as a healthcare attorney, he has interfaced with numerous commercial and government payers and is sensitive to the financially constrained healthcare environments in which they operate, and he understands and interfaces well with medical affairs as an active researcher who publishes articles in peer-reviewed medical journals. If outside vendors are part of the GVD development team, then normally Michael will play a pivotal role in vendor evaluation and selection and then serve as the point of contact for the vendors with the client firm. The GVD is a key component of a successful market access strategy. To that end, Michael performs the project planning, budgeting, work stream scheduling, interfacing with business units and franchises, vendor selection and oversight, monitoring, and quality assurance functions of a Project Manager. At the conclusion of the GVD, Michael disseminates the information through internal and external presentations, including attending payer meetings as the Health Economics & Outcomes Research and Value expert. Michael’s GVD experience is current.
|In 2013, Life Extension® announced a discovery that added precious years to people stricken with a lethal brain cancer called glioblastoma. The drug shown effective was valganciclovir, which is typically prescribed to treat cytomegalovirus.In 2015, CBS News 60 Minutes featured a story about research emanating from Duke University Medical Center showing complete responses in terminal glioblastoma patients who were administered a re-engineered polio virus directly into their brain tumor. The re-engineered virus prompted a powerful immune response against the viral-infected cancer cells that in some patients appear to eradicate their glioblastoma.The Magnitude of Human Carnage
Each month, 1,000 Americans die from glioblastoma. Up until now there was no cure. Survival from time of glioblastoma diagnosis averages only 15 months.
Valganciclovir extended survival to over four years in some studies. Doctors are cautiously optimistic that this re-engineered polio virus may be curative.
How to Enroll in Duke University Study
If you or someone you know suffers from glioblastoma, here is the patient criteria needed to participate in this Phase I clinical study:
1. You must have a recurrent glioblastoma (meaning you must already have failed at least one conventional treatment).
2. You can only have 1 area of tumor.
3. You must be fully functional, that means totally coherent and be able to walk and do things on your own.
If you said yes to all 3, call and speak to Brittany at 919-684-5301 and press option 1. Brittany will set you up to speak with the nurse who will continue with the medical screening process to see if you qualify to enter the trial.
Questions Life Extension Asked Duke University
Question: How many glioblastoma patients is Duke accepting?
Answer: There are no limits at this point. People have to qualify after they provide us with their medical histories and complete all the paperwork. If accepted, they then meet the nurses and doctors for their appointments.
Question: How long is the wait to begin treatment?
Answer: Treatment starts after the patient meets all the appointments and completes the screening. Patients start treatment as soon as everything is in order.
Question: Are younger people given preferential treatment?
Question: How many people are not getting treatment because of the favorable 60 Minutes report?
Answer: No one is rejected. We have had a lot of calls, but have been able to handle them. The pre-screening questions help to eliminate wasting time so we can continue the screening process and see if people qualify for the study after all the preliminary work is done. That is based on them meeting their appointment times, sending in the paperwork and meeting all the other necessary criteria, etc.
We Applaud Duke University…
It appears this re-engineered polio virus therapy could have been introduced sooner had it not been for bureaucratic hurdles regarding human clinical research that Congress has to fix. Glioblastoma is considered virtually 100% terminal and no human should be denied access to an experimental therapy that has a credible chance of working.
View the 60 Minutes segment about this new treatment for glioblastoma.
To inquire about qualifying for this Duke University study, call Brittany at 919-684-5301 and press option 1. If you meet eligibility criteria, Brittany will set you up to speak with the nurse who will continue with the medical screening process to see if you qualify to enter the trial.