I want to spend this entire week speaking on this J-CHIP medical management by microchip that is being developed in Baltimore but will come to all state health systems if it is left to be installed. First, I want to point out that it is a President running as a progressive liberal toting his desire to help the poor with education and health care-----sending in the most Republican of education and health policies-----and handing Johns Hopkins---the most neo-conservative health institution in the world in a city known to have the worst of health conditions and outcomes-----the green light in what will become a highly abusive health structure for profiteering and far-right health policy.
AGAIN----THEY ARE CALLING ALL OF THIS REPRESSIVE HEALTH POLICY OBAMACARE AND MAKING IT SEEM PROGRESSIVE WHEN THE GOALS ARE MAXIMIZING HEALTH INDUSTRY PROFITS USING WINNING AT ANY COST NEO-LIBERAL POLICY.
These microchip technologies have good applications. There are people who would want to have this kind of individualized medical oversight------the aging patient who forgets to take meds for example-----the chronically ill who worry about taking meds late or under the wrong biochemical conditions in their bodies. If this was not the age of global corporate neo-liberalism controlling our government----anything goes with no oversight and accountability----then we could see working these microchip technologies into health care in a responsible way.
KILLING HIPPOCRATIC OATH KILLS RESPONSIBLE HEALTH CARE.
I want to begin by outing that all of this BIOTech health policy that once functioned in the confines of REAL clinical trials that actually looked out for the welfare of people-----are now totally controlled by people working only to move products to market and maximize profits who fight any attempts at oversight and accountability. This means----WHAT IS COMING OUT OF CORPORATE UNIVERSITY BIOTECH FACILITIES WILL NOT BE GOOD SCIENCE-----
I worked in medical research for a few decades----I know the processes. For example, I worked in the development of PCR technology and biomarkers. I was part of prostate cancer treatment by biotechnology. Now, almost all of this was funded by Federal NIH and NCI funding and yet----they are patenting these processes and have used them far beyond the time professional data was proving them ineffective. We heard the same mantra----the development costs for these medical procedures must be recouped. So, the process in place under Clinton neo-liberals and Republicans under deregulation and no oversight and accountability is to allow medical products to market with little testing to recoup development costs and to monitor symptoms and efficacy on the general population.
Below you see how complex clinical trials have been----all of this trial system is being dismantled as too costly-----and we will not have data that tell us a medical procedure or process does not work---they will only release data that sells the idea that this product helps.
Long-Term Trial Results Show No Mortality Benefit from Annual Prostate Cancer Screening
New data from the Prostate, Lung, Colorectal and Ovarian (PLCO) randomized screening trial show that, after 13 years of follow up, men who underwent annual prostate cancer screening with prostate-specific antigen (PSA) testing and digital rectal examination (DRE) had a 12 percent higher incidence of prostate cancer than men in the control group but the same rate of death from the disease. No evidence of a mortality benefit was seen in subgroups defined by age, the presence of other illnesses, or pre-trial PSA testing. The results were published January 18, 2012, in the Journal of the National Cancer Institute.
When the PLCO researchers published their initial prostate screening results in 2009, which also revealed no prostate cancer mortality or overall mortality benefit from annual screening, critics countered that participants had not been followed long enough to detect a difference in prostate cancer mortality, if one existed.
“The natural history of prostate cancer is so long that 10 to 15 years of follow up is usually the window we look for” when determining the effectiveness of a screening intervention, explained first author Gerald Andriole, M.D., who is chief urologic surgeon at the Siteman Cancer Center at Barnes-Jewish Hospital in St. Louis and the Washington University School of Medicine.
The persistent increase in incidence of prostate cancer in the screening arm of the study may indicate that regular screening can lead to overdiagnosis—finding tumors that never would have caused symptoms or death. “Even if there was just a tiny mortality benefit [from prostate cancer screening], overdiagnosis wouldn’t be so bad if we didn’t hurt people. But we do hurt people by finding a lot of trivial cancers that are most often overtreated,” explained Dr. Andriole.
The PLCO began in 1993 and enrolled men through mid-2001. More than 38,000 men were randomly assigned to annual screening for 6 years (including DRE for the first 4 years and PSA testing for all 6), and the same number of men were assigned to usual care.
Because prostate cancer screening is so common, more than half of the participants in the control arm underwent at least one prostate cancer screening test outside the trial. This contamination made it more difficult to determine whether annual testing affected mortality. However, “the level of screening in the intervention arm was substantially greater than that in the control arm throughout the trial screening period,” wrote the authors.
“Every time we screened [in the intervention arm] we got a bump of excess cases,” said Philip Prorok, Ph.D., a lead NCI investigator on the study. “What we can’t say for sure is whether we would have seen more of an effect on mortality had there been absolutely no screening in the control arm.”
Another recent large trial, called the European Randomized Study of Screening for Prostate Cancer, did report a mortality benefit for prostate cancer screening. Although that trial had less contamination in the control arm, it had other limitations that could bias the results, such as differences in the treatments given to men in the screening and control arms.
To help reconcile the differing results from these two trials—the largest trials to date of organized prostate cancer screening—an effort is under way by the NCI-funded Cancer Intervention and Surveillance Modeling Network (CISNET) to use mathematical modeling to tease out how differences in the trial designs and populations may have contributed to the disparate trial results, explained Paul Pinsky, Ph.D., an NCI investigator on the PLCO trial and consultant to the CISNET project.
“Even though the results seem to be disparate, because one [trial] found a [statistically] significant protective effect [on prostate cancer mortality] and one didn’t, it could be because of the ways the trials were designed and carried out,” he said. The CISNET study began in 2011 and is examining data from the two trials.
Men and their health providers agree that a more definitive answer is needed as doctors and policy makers seek to understand which, if any, men may benefit from routine prostate cancer screening. In October 2011, the United States Preventive Services Task Force released new draft guidelines for prostate cancer screening for public comment. The new draft guidelines, which are based in part on PLCO findings, recommend against routine PSA testing in men who do not have prostate cancer symptoms.
Some doctors think the new recommendations go too far in not accounting for the informed decisions of individual men. “If prostate cancer constitutes a continuum of disease and its overdiagnosis and overtreatment are mainly limited to low-grade disease, then instead of completely eliminating the potential benefits of screening along with the risks, why not consider managing low-risk patients differently?” asked Jeri Kim, M.D., and John W. Davis, M.D., of the University of Texas M. D. Anderson Cancer Center in a commentary published December 28, 2011, in JAMA.
Practice appears to be moving in this direction, with a greater emphasis on active surveillance instead of immediate treatment for some men who have prostate cancer that is thought to be at low risk of progressing. A big advance, explained Dr. Andriole, would be the ability to predict, even before a biopsy, whether a man with an elevated PSA level is likely to have an aggressive versus a nonaggressive cancer.
“There’s a lot of effort now being put into this, and not just for prostate cancer, but for a lot of other cancer types as well,” added Dr. Prorok. “If we diagnose someone with symptoms, or you find something on a screening test, can we eventually find a way to determine for which individuals the cancers are in fact aggressive and need more aggressive treatment, versus some that need less aggressive treatment or don’t need any treatment at all?”
Researchers are looking for biomarkers, including genes and proteins, that may give clues to a cancer’s aggressiveness. “If we could selectively change our criteria for biopsy such that only men who are at high risk for aggressive cancer get biopsied, we might be able to substantially shift the overall risk/benefit [ratio] of screening,” said Dr. Andriole.
Biotechnol Healthc. 2004 May; 1(2): 37–41. PMCID: PMC3555164
Explaining The Cost Of Biotech Therapies
BILL EDELMAN
ALL OR NOTHING“The biotech drug market is different from the traditional retail market, in that you have high-cost drugs and few people taking them. Many of these are orphan-status drugs that get propelled through the FDA approval process as a result,” says Greg S. Weishar, president and CEO of PharmaCare Management Services, a pharmacy benefit manager and parent company of PharmaCare Specialty Pharmacy. “Health plans are in the insurance business, and they’re in a dilemma. They’re trying to control costs, and these drugs have very few alternatives.”
Weishar gives this example: For multiple sclerosis, there are few, if any, viable therapeutic alternatives to interferon β-1a (Avonex or Rebif) — the gold standard for MS patients for MCOs.
When the MCO must choose between a chemical therapy and a biotech therapy, the principal variables to weigh are safety, efficacy, and cost. But when the choice is between covering a biotech therapy or providing no viable coverage, the equation is simpler, because depriving an MS patient of the only effective treatment available invites a public relations disaster.
Though only a few patients in a given plan population are diagnosed each year, Weishar observes, the MCO providing this therapy takes a big financial hit.
“At its most fundamental level, insurance is about taking care of people who have a very expensive condition to treat. That’s what it is all about; insurance is catastrophic,” Weishar says. “It’s a question of risk exposure to the insurance company. Only 1 percent of its population needs the drug. The question is, how should the insurance company or health plan manage that 1 percent of covered members who need Avonex [or Rebif]? Probably, the best way to manage those patients is to give them the drug.”
Jeff Kimmell, RPh, vice president and general manager of pharmacy for drugstore.com, agrees that the nature of orphan biotech drugs means that they have an easier path through the MCO approval process: “Uniqueness buys you something, though MCOs will still question whether the patient needs that particular drug. If you can find the item that is unique and provides 5 or 10 percent more effectiveness or 5 to 10 percent fewer side effects, that is what patients will want and physicians will demand. If physicians tell the MCOs, ‘Don’t make me jump through hoops; this is, far and away, the better product,’ the MCOs will start paying for it without question.”
VIABLE OPTIONS
In contrast to Avonex, omalizumab (Xolair) has multiple competitors and is used to treat a common condition, asthma. “Because there are some quite good treatment alternatives for asthma, step therapy is a viable strategy and health plans have the ability to winnow that one tenth of 1 percent of asthma patients who really need Xolair,” Weishar points out. At $700 per prescription, Xolair is reserved for those few patients who cannot obtain acceptable results using chemical-based options.
Indications for the use of biotech drugs are expanding, and physicians are prescribing them increasingly. Joel Owerbach, PharmD, vice president and chief pharmacy officer for Excellus BlueCross/BlueShield estimates that the expense of biotech drug therapy increases by 30 to 50 percent annually. To decrease waste and its inherent expense, ensuring appropriate use is vital. “We need to evaluate whether a person should get the drug, determine who has the best chance of responding to it, and make sure we get the best return on the investment, which means getting the best outcome,” Owerbach says. “We need adequate proof that the patient is responding to treatment, the drug is controlling the condition, and the patient is going to avoid complications later.”
Kimmell likens this paradigm to the emergence of the earliest mass-market drugs. “When we first developed traditional pharmaceuticals, we were able to develop a few strains to take care of everybody and his brother. Anybody in the world who had an infection was able to take penicillin and get better,” Kimmell observes. “Then we had to make erythromycin because of penicillin allergies. Now, we’ve progressed to biotechnological drugs.”
Pharmacogenomics likely will yield effective drugs to people with similar genetic make-ups. Despite physical differences, persons can be so genetically alike that they can be grouped; a drug custom-designed to produce positive clinical outcomes in them may not be as effective for other genetic types. Yet finding patients who will respond best to a specific therapy necessitates biologic assays costing $100 to $700 or more. Many assays are either not covered by health plans or are covered at the Medicare rate — which often amounts to a fraction of the cost of the test.
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Not many people know or understand what has been the focus of medical research for two decades-----with Wall Street corporations bought and sold like crazy. BioTechnology has taken the concept I show above-----finding genetic markers and then targeting those markers with different treatments----sometimes involving light, chemicals, and even living combatants. These technologies are as interesting as all nanotech and robotics being installed. The problem falls in the variability and arbitrary nature of these processes. PHARMA used a chemical compound as in aspirin that was known to migrate through body systems to the point of inflamation.....the precision needed for these new technologies----and the specificity of applications to individuals and treatment will assure problems for far into the future----a few decades let's say. The J-CHIP being developed by Johns Hopkins seeks to integrate what is an already complex set of biotechnical activities.
When Hopkins says it is taking these technologies out into Baltimore's underserved communities for testing and development----we are talking very serious medical invasion. Just the faith in a technology's reliability in releasing whatever chemical treatment into someone's body remotely -------and then the measurements and data capture-----can be a great risk. Not to mention the intent to use treatments that are as of yet not proven efficacious.... meaning providing improvement.
HOW MUCH CLINICAL TRIAL TESTING ON HUMANS HAS THESE TECHNOLOGIES HAD -----OR IS THIS MOSTLY LAB TESTED?
We have no Federal public health or Baltimore City public health reporting these figures that I know of. IMEC below is a partner global corporation in these technology applications ----having a broad field of applications including human body tracking. We know it is these corporations and their data being presented as successful -----and the Federal government whether Department of Health and Human Services or the Food and Drug Administration are NOT LOOKING AT THE VALIDITY OF THESE DATA.
About IMEC Technologies
IMEC Technologies is a supplier of data collection and Track and Trace solutions for use in regulated industries and healthcare environments. Our customers include some of the world’s leading organisation including Pfizer, American Airlines, Kerry Group and GlaxoSmithKline. Headquartered in Urbana, Illinois the company also has development and sales offices in the UK and Ireland.
IMEC Technologies’ solutions include
Biomedical chip technology: Small but powerful tools for our health
By Kris Verstreken, MD, PhD and Hanne Degans, PhD – Imec
March 9, 2011 — How will nanoelectronics and nanotechnology contribute to prevention, diagnosis, therapy and post therapy of diseases? Will the introduction of nanoelectronics in pharmacy bring a breakthrough in developing revolutionary therapies such as immuno- or gene therapy? The continued scaling of chip technology resulted in nanoelectronics dimensions evolving increasingly toward cell dimensions, cell parts, and even molecules. As a result, electronic and biological functions can interact, and new applications arise in the area of biomedical electronics.
Biosensor technologies combining a biological identifying element (protein, DNA/RNA, virus, cell) with a physicochemical detector component are widely applicable in drug development at all stages of the development track (from lab to clinical tests), for localized therapy, for inexpensive and comfortable tools for post-therapy, for early diagnosis (genetic profiling) and even for prevention. Innovative biosensors based on nanoelectronics and nanotechnology will be key to creating a better, patient-oriented and less expensive healthcare in the future.
The pharmaceutical industry’s interest in disease diagnosis is growing. These days, diagnosis is being carried out especially by post-symptomatic analysis and diagnosis in laboratories. In the future, technologies based on nano-electronics will enable diagnosis by means of genetic or other early screening of patients, and therapies will be administered with personalized observation. Biomedical electronics will also improve treatment efficiencies and reduce its costs. Sensor-based technologies will enable localized therapy, only intervening when necessary and reducing the side effects of a treatment. Post-therapy based on nanoelectronics will be less burdensome on the daily life of the patient. Such instruments should be low-cost, portable, and comfortable in maintenance and operation.
An essential aspect for the pharmaceutical industry is that new measuring methods are not only fast and efficient; they should also be widely applicable and therefore can be produced in large volumes at reasonable cost. The industry is looking for instruments that can be used not only for drug development, but also during the post-therapeutic stage, to keep an eye on the patients that participated in the clinical tests for drug development. These instruments that will be used for genetic profiling for disease diagnosis and prevention.
Figure. General concept of a biosensor to detect a target in blood.
New measuring methods using nanoelectronics-based biosensors are of key interest to the pharmaceutical industry because of the variety of applications. They are useful for diagnosis, but also in lab studies (genetic profiling), for preclinical and clinical tests, and for therapy and post therapy. Molecular biosensors detect a biomarker (antibodies, enzymes, DNA, diseased cells, foreign substances such as radioisotopes) in blood. They allow fast, exact and very specific measurement of a biomarker or of several different biomarkers at the same time. Biomarkers are blood substances that are characteristic for a certain biological condition and therefore can be used to determine diseases. A biomarker can be a genetic code within the DNA that is characteristic for a particular disease; but it can also be a diseased cell, such as a cancer cell. Additionally, biomarkers can be foreign substances such as radio isotopes, which are being injected into the blood to examine, for example, organ functions. In order to detect biomarkers in the blood, a blood sample needs to be analyzed. Currently, time-consuming and expensive lab tests have to be carried out in several steps to detect biomarkers. When molecular biosensors are integrated into an electronic system (lab-on-chip), detection can be done much faster and cheaper. Imec develops lab-on-chip systems, such as a breast cancer diagnostic system that can detect cancer cells.
Chip technology’s role in healthcare has the world’s attention. Nanoelectronics will help more patients than we can today, at a lower cost price and for a larger number of diseases, or at least such is the hope. Imec’s research supports the necessary innovation of biomedical instruments for prevention, diagnosis and therapy. Within its life science program, imec cooperates with industrial partners for smart electronic systems in order to study diseases, diagnosis and disease therapy: lab-on-chip systems, nanoparticles for treatment of diseases, technologies for intelligent implants, etc.
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This list of research on microchip delivery systems is not all that has been done of course----I simply wanted to show how new all of this is-----below you see the first in human testing in 2012 for goodness sake. The rest fall within the last decade. Clinical trials have historically taken a decade or so and that was not for basic science like this which takes much longer. Because we have Clinton neo-liberals and Bush neo-cons making all policy about maximizing profit-----the goals here are simply to move products to market as fast as possible and then pay off people getting harmed.
If you are like me----regardless of the efficacy and research ---I do not want to be forced to be involved in remote medicine. What Affordable Care Act did was to require health insurance and gave corporations the power to tell citizens what they must submit to in order to stay on a health plan. They will boost the rates if you decline to a point you cannot afford----just as they are pushing all this SMART METER technology on everyone.
Publications Farra, Robert, et al.
"First-in-human testing of a wirelessly controlled drug delivery microchip."
Science Translational Medicine 4.122 (2012): 122ra21-122ra21.
This first-in-human clinical trial evaluated the pharmacokinetic profiles of human parathyroid hormone (hPTH(1–34))delivered by the microchip-based implant versus subcutaneous injections. Results indicated that the release profile of hPTH(1–34) from the microchip-based implant was comparable and bioequivalent to the profile of subcutaneous injections. In addition, patients reported positively when surveyed about their implant experience.
Prescott, James H., et al.
"Chronic, programmed polypeptide delivery from an implanted, multireservoir microchip device."
Nature biotechnology 24.4 (2006): 437-438.
This first-in-animal study evaluated the ability of the microchip-based implant to deliver leuprolide (an analog of a luteinizing hormone-releasing hormone that is marketed for the treatment of prostate cancer and endometriosis) over a 6-month period in dogs. Results supported the feasibility of applying microchip-based implant technology to deliver other therapeutic peptides and proteins. In addition, the study suggested that drug delivery from an array of discrete reservoirs is not restricted to solution-phase drug formulations, and that stability-optimized, solid-phase drug formulations can be packaged and released in vivo.
Grayson, Amy C. Richards, et al.
"Multi-pulse drug delivery from a resorbable polymeric microchip device."
Nature materials 2.11 (2003): 767-772.
The Microchips Biotech IP portfolio includes both electronically-controlled reservoir implants as well as preprogrammed, non-electronic reservoir-based implants, made of resorbable polymers. This study evaluated the functionality of a biodegradable microchip implant and demonstrated that timed, pulsatile delivery is possible by varying the molecular mass of the membranes covering each reservoir.
AGAIN----THEY ARE CALLING ALL OF THIS REPRESSIVE HEALTH POLICY OBAMACARE AND MAKING IT SEEM PROGRESSIVE WHEN THE GOALS ARE MAXIMIZING HEALTH INDUSTRY PROFITS USING WINNING AT ANY COST NEO-LIBERAL POLICY.
These microchip technologies have good applications. There are people who would want to have this kind of individualized medical oversight------the aging patient who forgets to take meds for example-----the chronically ill who worry about taking meds late or under the wrong biochemical conditions in their bodies. If this was not the age of global corporate neo-liberalism controlling our government----anything goes with no oversight and accountability----then we could see working these microchip technologies into health care in a responsible way.
KILLING HIPPOCRATIC OATH KILLS RESPONSIBLE HEALTH CARE.
I want to begin by outing that all of this BIOTech health policy that once functioned in the confines of REAL clinical trials that actually looked out for the welfare of people-----are now totally controlled by people working only to move products to market and maximize profits who fight any attempts at oversight and accountability. This means----WHAT IS COMING OUT OF CORPORATE UNIVERSITY BIOTECH FACILITIES WILL NOT BE GOOD SCIENCE-----
I worked in medical research for a few decades----I know the processes. For example, I worked in the development of PCR technology and biomarkers. I was part of prostate cancer treatment by biotechnology. Now, almost all of this was funded by Federal NIH and NCI funding and yet----they are patenting these processes and have used them far beyond the time professional data was proving them ineffective. We heard the same mantra----the development costs for these medical procedures must be recouped. So, the process in place under Clinton neo-liberals and Republicans under deregulation and no oversight and accountability is to allow medical products to market with little testing to recoup development costs and to monitor symptoms and efficacy on the general population.
Below you see how complex clinical trials have been----all of this trial system is being dismantled as too costly-----and we will not have data that tell us a medical procedure or process does not work---they will only release data that sells the idea that this product helps.
Long-Term Trial Results Show No Mortality Benefit from Annual Prostate Cancer Screening
New data from the Prostate, Lung, Colorectal and Ovarian (PLCO) randomized screening trial show that, after 13 years of follow up, men who underwent annual prostate cancer screening with prostate-specific antigen (PSA) testing and digital rectal examination (DRE) had a 12 percent higher incidence of prostate cancer than men in the control group but the same rate of death from the disease. No evidence of a mortality benefit was seen in subgroups defined by age, the presence of other illnesses, or pre-trial PSA testing. The results were published January 18, 2012, in the Journal of the National Cancer Institute.
When the PLCO researchers published their initial prostate screening results in 2009, which also revealed no prostate cancer mortality or overall mortality benefit from annual screening, critics countered that participants had not been followed long enough to detect a difference in prostate cancer mortality, if one existed.
“The natural history of prostate cancer is so long that 10 to 15 years of follow up is usually the window we look for” when determining the effectiveness of a screening intervention, explained first author Gerald Andriole, M.D., who is chief urologic surgeon at the Siteman Cancer Center at Barnes-Jewish Hospital in St. Louis and the Washington University School of Medicine.
The persistent increase in incidence of prostate cancer in the screening arm of the study may indicate that regular screening can lead to overdiagnosis—finding tumors that never would have caused symptoms or death. “Even if there was just a tiny mortality benefit [from prostate cancer screening], overdiagnosis wouldn’t be so bad if we didn’t hurt people. But we do hurt people by finding a lot of trivial cancers that are most often overtreated,” explained Dr. Andriole.
The PLCO began in 1993 and enrolled men through mid-2001. More than 38,000 men were randomly assigned to annual screening for 6 years (including DRE for the first 4 years and PSA testing for all 6), and the same number of men were assigned to usual care.
Because prostate cancer screening is so common, more than half of the participants in the control arm underwent at least one prostate cancer screening test outside the trial. This contamination made it more difficult to determine whether annual testing affected mortality. However, “the level of screening in the intervention arm was substantially greater than that in the control arm throughout the trial screening period,” wrote the authors.
“Every time we screened [in the intervention arm] we got a bump of excess cases,” said Philip Prorok, Ph.D., a lead NCI investigator on the study. “What we can’t say for sure is whether we would have seen more of an effect on mortality had there been absolutely no screening in the control arm.”
Another recent large trial, called the European Randomized Study of Screening for Prostate Cancer, did report a mortality benefit for prostate cancer screening. Although that trial had less contamination in the control arm, it had other limitations that could bias the results, such as differences in the treatments given to men in the screening and control arms.
To help reconcile the differing results from these two trials—the largest trials to date of organized prostate cancer screening—an effort is under way by the NCI-funded Cancer Intervention and Surveillance Modeling Network (CISNET) to use mathematical modeling to tease out how differences in the trial designs and populations may have contributed to the disparate trial results, explained Paul Pinsky, Ph.D., an NCI investigator on the PLCO trial and consultant to the CISNET project.
“Even though the results seem to be disparate, because one [trial] found a [statistically] significant protective effect [on prostate cancer mortality] and one didn’t, it could be because of the ways the trials were designed and carried out,” he said. The CISNET study began in 2011 and is examining data from the two trials.
Men and their health providers agree that a more definitive answer is needed as doctors and policy makers seek to understand which, if any, men may benefit from routine prostate cancer screening. In October 2011, the United States Preventive Services Task Force released new draft guidelines for prostate cancer screening for public comment. The new draft guidelines, which are based in part on PLCO findings, recommend against routine PSA testing in men who do not have prostate cancer symptoms.
Some doctors think the new recommendations go too far in not accounting for the informed decisions of individual men. “If prostate cancer constitutes a continuum of disease and its overdiagnosis and overtreatment are mainly limited to low-grade disease, then instead of completely eliminating the potential benefits of screening along with the risks, why not consider managing low-risk patients differently?” asked Jeri Kim, M.D., and John W. Davis, M.D., of the University of Texas M. D. Anderson Cancer Center in a commentary published December 28, 2011, in JAMA.
Practice appears to be moving in this direction, with a greater emphasis on active surveillance instead of immediate treatment for some men who have prostate cancer that is thought to be at low risk of progressing. A big advance, explained Dr. Andriole, would be the ability to predict, even before a biopsy, whether a man with an elevated PSA level is likely to have an aggressive versus a nonaggressive cancer.
“There’s a lot of effort now being put into this, and not just for prostate cancer, but for a lot of other cancer types as well,” added Dr. Prorok. “If we diagnose someone with symptoms, or you find something on a screening test, can we eventually find a way to determine for which individuals the cancers are in fact aggressive and need more aggressive treatment, versus some that need less aggressive treatment or don’t need any treatment at all?”
Researchers are looking for biomarkers, including genes and proteins, that may give clues to a cancer’s aggressiveness. “If we could selectively change our criteria for biopsy such that only men who are at high risk for aggressive cancer get biopsied, we might be able to substantially shift the overall risk/benefit [ratio] of screening,” said Dr. Andriole.
- Posted: February 17, 2012
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- This is a long article but if you glance through you will see what is an industry being built and released to the public BEFORE all of the foundation principles are identified and validated. These medical processes are now structured like computer technology where the drive is to roll out one product after the other with no research as to whether it is a positive value for society or if these technologies will be used for the public good. THERE IS NO ETHOS OR MORAL DISCUSSION HAPPENING AT ALL. Social democratic principles built all that oversight and accountability and a clinical trial structure that made sure all sides of medical advancement were studied-----Clinton neo-liberals and Republicans deregulated and dismantled all this because the goal is to get new products to market....bad effects will be mitigated with money payoffs as always.
The most blaring issues raised by this article and it is the number 1 reason people do not like Federal funding and public health involved in all this-----IT IS VERY COSTLY BECAUSE IT TARGETS SPECIFIC GENETIC CHARACTERISTICS THAT MAKE EACH TREATMENT UNIQUE TO A SMALL GROUP OF PEOPLE. INDIVIDUALIZED MEDICINE WILL ONLY BE AFFORDED BY AFFLUENT PEOPLE WITH THE HIGHEST LEVEL OF PRIVATE INSURANCE.
Fast forward to BIOTech facilities tied to mostly Ivy League universities geared to global health tourism. Meanwhile, over 80% of Americans are being tied to these telemedicine-----microchip level of care. THE ENTIRE PROCESS IS BACKWARDS BEING BUILT FOR VERY FEW. It does not take a rocket scientist to know that these techologies will be made main stream and be given over and over again earning billions of dollars for corporations and then we will see the data that shows most of those tests proved/improved nothing. This is because they are not taking the time to develop the basic science.
MEANWHILE, LAW FIRMS TIED TO MEDICAL MALPRACTICE HAVE CLASS ACTION LAWSUITS SOARING FOR BAD MEDICINE----THEY EVEN HAVE THIS CATEGORY----BAD MEDICINE.
Biotechnol Healthc. 2004 May; 1(2): 37–41. PMCID: PMC3555164
Explaining The Cost Of Biotech Therapies
BILL EDELMAN
ALL OR NOTHING“The biotech drug market is different from the traditional retail market, in that you have high-cost drugs and few people taking them. Many of these are orphan-status drugs that get propelled through the FDA approval process as a result,” says Greg S. Weishar, president and CEO of PharmaCare Management Services, a pharmacy benefit manager and parent company of PharmaCare Specialty Pharmacy. “Health plans are in the insurance business, and they’re in a dilemma. They’re trying to control costs, and these drugs have very few alternatives.”
Weishar gives this example: For multiple sclerosis, there are few, if any, viable therapeutic alternatives to interferon β-1a (Avonex or Rebif) — the gold standard for MS patients for MCOs.
When the MCO must choose between a chemical therapy and a biotech therapy, the principal variables to weigh are safety, efficacy, and cost. But when the choice is between covering a biotech therapy or providing no viable coverage, the equation is simpler, because depriving an MS patient of the only effective treatment available invites a public relations disaster.
Though only a few patients in a given plan population are diagnosed each year, Weishar observes, the MCO providing this therapy takes a big financial hit.
“At its most fundamental level, insurance is about taking care of people who have a very expensive condition to treat. That’s what it is all about; insurance is catastrophic,” Weishar says. “It’s a question of risk exposure to the insurance company. Only 1 percent of its population needs the drug. The question is, how should the insurance company or health plan manage that 1 percent of covered members who need Avonex [or Rebif]? Probably, the best way to manage those patients is to give them the drug.”
Jeff Kimmell, RPh, vice president and general manager of pharmacy for drugstore.com, agrees that the nature of orphan biotech drugs means that they have an easier path through the MCO approval process: “Uniqueness buys you something, though MCOs will still question whether the patient needs that particular drug. If you can find the item that is unique and provides 5 or 10 percent more effectiveness or 5 to 10 percent fewer side effects, that is what patients will want and physicians will demand. If physicians tell the MCOs, ‘Don’t make me jump through hoops; this is, far and away, the better product,’ the MCOs will start paying for it without question.”
VIABLE OPTIONS
In contrast to Avonex, omalizumab (Xolair) has multiple competitors and is used to treat a common condition, asthma. “Because there are some quite good treatment alternatives for asthma, step therapy is a viable strategy and health plans have the ability to winnow that one tenth of 1 percent of asthma patients who really need Xolair,” Weishar points out. At $700 per prescription, Xolair is reserved for those few patients who cannot obtain acceptable results using chemical-based options.
Indications for the use of biotech drugs are expanding, and physicians are prescribing them increasingly. Joel Owerbach, PharmD, vice president and chief pharmacy officer for Excellus BlueCross/BlueShield estimates that the expense of biotech drug therapy increases by 30 to 50 percent annually. To decrease waste and its inherent expense, ensuring appropriate use is vital. “We need to evaluate whether a person should get the drug, determine who has the best chance of responding to it, and make sure we get the best return on the investment, which means getting the best outcome,” Owerbach says. “We need adequate proof that the patient is responding to treatment, the drug is controlling the condition, and the patient is going to avoid complications later.”
Kimmell likens this paradigm to the emergence of the earliest mass-market drugs. “When we first developed traditional pharmaceuticals, we were able to develop a few strains to take care of everybody and his brother. Anybody in the world who had an infection was able to take penicillin and get better,” Kimmell observes. “Then we had to make erythromycin because of penicillin allergies. Now, we’ve progressed to biotechnological drugs.”
Pharmacogenomics likely will yield effective drugs to people with similar genetic make-ups. Despite physical differences, persons can be so genetically alike that they can be grouped; a drug custom-designed to produce positive clinical outcomes in them may not be as effective for other genetic types. Yet finding patients who will respond best to a specific therapy necessitates biologic assays costing $100 to $700 or more. Many assays are either not covered by health plans or are covered at the Medicare rate — which often amounts to a fraction of the cost of the test.
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Not many people know or understand what has been the focus of medical research for two decades-----with Wall Street corporations bought and sold like crazy. BioTechnology has taken the concept I show above-----finding genetic markers and then targeting those markers with different treatments----sometimes involving light, chemicals, and even living combatants. These technologies are as interesting as all nanotech and robotics being installed. The problem falls in the variability and arbitrary nature of these processes. PHARMA used a chemical compound as in aspirin that was known to migrate through body systems to the point of inflamation.....the precision needed for these new technologies----and the specificity of applications to individuals and treatment will assure problems for far into the future----a few decades let's say. The J-CHIP being developed by Johns Hopkins seeks to integrate what is an already complex set of biotechnical activities.
When Hopkins says it is taking these technologies out into Baltimore's underserved communities for testing and development----we are talking very serious medical invasion. Just the faith in a technology's reliability in releasing whatever chemical treatment into someone's body remotely -------and then the measurements and data capture-----can be a great risk. Not to mention the intent to use treatments that are as of yet not proven efficacious.... meaning providing improvement.
HOW MUCH CLINICAL TRIAL TESTING ON HUMANS HAS THESE TECHNOLOGIES HAD -----OR IS THIS MOSTLY LAB TESTED?
We have no Federal public health or Baltimore City public health reporting these figures that I know of. IMEC below is a partner global corporation in these technology applications ----having a broad field of applications including human body tracking. We know it is these corporations and their data being presented as successful -----and the Federal government whether Department of Health and Human Services or the Food and Drug Administration are NOT LOOKING AT THE VALIDITY OF THESE DATA.
About IMEC Technologies
IMEC Technologies is a supplier of data collection and Track and Trace solutions for use in regulated industries and healthcare environments. Our customers include some of the world’s leading organisation including Pfizer, American Airlines, Kerry Group and GlaxoSmithKline. Headquartered in Urbana, Illinois the company also has development and sales offices in the UK and Ireland.
IMEC Technologies’ solutions include
- HazMat T&T, a Waste Management system used to track and trace all waste streams within organizations such as hospitals, oil and gas companies, chemical and pharmaceutical companies;
- Inspector T&T a web based inspection system that will schedule, track, manage and report on any type of equipment, asset, location inspection or audit on a predefined planned schedule or on and ad hoc basis;
- Navigation Material Movements, an RF Material Tracking System to track and report on material movements within a manufacturing company, Navigation Enterprise Labelling(NEL) which is a FDA and GMP compliant label design, approval, control, printing and reconciliation system for use in life science industries.
Biomedical chip technology: Small but powerful tools for our health
By Kris Verstreken, MD, PhD and Hanne Degans, PhD – Imec
March 9, 2011 — How will nanoelectronics and nanotechnology contribute to prevention, diagnosis, therapy and post therapy of diseases? Will the introduction of nanoelectronics in pharmacy bring a breakthrough in developing revolutionary therapies such as immuno- or gene therapy? The continued scaling of chip technology resulted in nanoelectronics dimensions evolving increasingly toward cell dimensions, cell parts, and even molecules. As a result, electronic and biological functions can interact, and new applications arise in the area of biomedical electronics.
Biosensor technologies combining a biological identifying element (protein, DNA/RNA, virus, cell) with a physicochemical detector component are widely applicable in drug development at all stages of the development track (from lab to clinical tests), for localized therapy, for inexpensive and comfortable tools for post-therapy, for early diagnosis (genetic profiling) and even for prevention. Innovative biosensors based on nanoelectronics and nanotechnology will be key to creating a better, patient-oriented and less expensive healthcare in the future.
The pharmaceutical industry’s interest in disease diagnosis is growing. These days, diagnosis is being carried out especially by post-symptomatic analysis and diagnosis in laboratories. In the future, technologies based on nano-electronics will enable diagnosis by means of genetic or other early screening of patients, and therapies will be administered with personalized observation. Biomedical electronics will also improve treatment efficiencies and reduce its costs. Sensor-based technologies will enable localized therapy, only intervening when necessary and reducing the side effects of a treatment. Post-therapy based on nanoelectronics will be less burdensome on the daily life of the patient. Such instruments should be low-cost, portable, and comfortable in maintenance and operation.
An essential aspect for the pharmaceutical industry is that new measuring methods are not only fast and efficient; they should also be widely applicable and therefore can be produced in large volumes at reasonable cost. The industry is looking for instruments that can be used not only for drug development, but also during the post-therapeutic stage, to keep an eye on the patients that participated in the clinical tests for drug development. These instruments that will be used for genetic profiling for disease diagnosis and prevention.
Figure. General concept of a biosensor to detect a target in blood.
New measuring methods using nanoelectronics-based biosensors are of key interest to the pharmaceutical industry because of the variety of applications. They are useful for diagnosis, but also in lab studies (genetic profiling), for preclinical and clinical tests, and for therapy and post therapy. Molecular biosensors detect a biomarker (antibodies, enzymes, DNA, diseased cells, foreign substances such as radioisotopes) in blood. They allow fast, exact and very specific measurement of a biomarker or of several different biomarkers at the same time. Biomarkers are blood substances that are characteristic for a certain biological condition and therefore can be used to determine diseases. A biomarker can be a genetic code within the DNA that is characteristic for a particular disease; but it can also be a diseased cell, such as a cancer cell. Additionally, biomarkers can be foreign substances such as radio isotopes, which are being injected into the blood to examine, for example, organ functions. In order to detect biomarkers in the blood, a blood sample needs to be analyzed. Currently, time-consuming and expensive lab tests have to be carried out in several steps to detect biomarkers. When molecular biosensors are integrated into an electronic system (lab-on-chip), detection can be done much faster and cheaper. Imec develops lab-on-chip systems, such as a breast cancer diagnostic system that can detect cancer cells.
Chip technology’s role in healthcare has the world’s attention. Nanoelectronics will help more patients than we can today, at a lower cost price and for a larger number of diseases, or at least such is the hope. Imec’s research supports the necessary innovation of biomedical instruments for prevention, diagnosis and therapy. Within its life science program, imec cooperates with industrial partners for smart electronic systems in order to study diseases, diagnosis and disease therapy: lab-on-chip systems, nanoparticles for treatment of diseases, technologies for intelligent implants, etc.
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This list of research on microchip delivery systems is not all that has been done of course----I simply wanted to show how new all of this is-----below you see the first in human testing in 2012 for goodness sake. The rest fall within the last decade. Clinical trials have historically taken a decade or so and that was not for basic science like this which takes much longer. Because we have Clinton neo-liberals and Bush neo-cons making all policy about maximizing profit-----the goals here are simply to move products to market as fast as possible and then pay off people getting harmed.
If you are like me----regardless of the efficacy and research ---I do not want to be forced to be involved in remote medicine. What Affordable Care Act did was to require health insurance and gave corporations the power to tell citizens what they must submit to in order to stay on a health plan. They will boost the rates if you decline to a point you cannot afford----just as they are pushing all this SMART METER technology on everyone.
Publications Farra, Robert, et al.
"First-in-human testing of a wirelessly controlled drug delivery microchip."
Science Translational Medicine 4.122 (2012): 122ra21-122ra21.
This first-in-human clinical trial evaluated the pharmacokinetic profiles of human parathyroid hormone (hPTH(1–34))delivered by the microchip-based implant versus subcutaneous injections. Results indicated that the release profile of hPTH(1–34) from the microchip-based implant was comparable and bioequivalent to the profile of subcutaneous injections. In addition, patients reported positively when surveyed about their implant experience.
Prescott, James H., et al.
"Chronic, programmed polypeptide delivery from an implanted, multireservoir microchip device."
Nature biotechnology 24.4 (2006): 437-438.
This first-in-animal study evaluated the ability of the microchip-based implant to deliver leuprolide (an analog of a luteinizing hormone-releasing hormone that is marketed for the treatment of prostate cancer and endometriosis) over a 6-month period in dogs. Results supported the feasibility of applying microchip-based implant technology to deliver other therapeutic peptides and proteins. In addition, the study suggested that drug delivery from an array of discrete reservoirs is not restricted to solution-phase drug formulations, and that stability-optimized, solid-phase drug formulations can be packaged and released in vivo.
Grayson, Amy C. Richards, et al.
"Multi-pulse drug delivery from a resorbable polymeric microchip device."
Nature materials 2.11 (2003): 767-772.
The Microchips Biotech IP portfolio includes both electronically-controlled reservoir implants as well as preprogrammed, non-electronic reservoir-based implants, made of resorbable polymers. This study evaluated the functionality of a biodegradable microchip implant and demonstrated that timed, pulsatile delivery is possible by varying the molecular mass of the membranes covering each reservoir.
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