Adding temozolomide chemotherapy to short-course radiation therapy (RT) in elderly patients with newly diagnosed glioblastoma significantly improves overall survival (OS) and progression-free survival (PFS), according to results from a global phase III trial presented at the 2016 Meeting of the American Society of Clinical Oncology (ASCO) held recently in Chicago, IL, US. [ASCO 2016, abstract LBA2]
“This is the first study to test the combination of temozolomide plus RT in older individuals, who account for half of all patients with the disease,” noted lead investigator Dr. James Perry of the Sunnybrook Health Sciences Centre in Toronto, Canada. “In previous studies, a trend of decreasing benefit with the addition of temozolomide at increasing age was observed, and the question remained unanswered until now.”
A total of 562 patients aged ≥65 years (median, 73 years) with histologically confirmed newly diagnosed glioblastoma were randomized to receive short-course RT (40 Gy in 15 fractions over 3 weeks) or RT plus 3 weeks of concomitant temozolomide followed by monthly adjuvant temozolomide until disease progression or until completion of 12 cycles.
“RT plus temozolomide significantly improved OS compared with RT alone. The median survival was prolonged from 7.6 to 9.3 months, translating into a 33 percent reduction in the risk of death (p<0.0001),” Perry said. “Although the difference may seem modest, adding temozolomide significantly increased the chances of surviving for 2 or 3 years. The 1- and 2-year survival rates were 37.8 and 10.4 percent with RT plus temozolomide vs 22.2 and 2.8 percent with RT alone.
PFS also improved from 3.9 months in the RT arm to 5.3 months in the combination therapy arm (p<0.0001; hazard ratio [HR], 0.50).
Perry added that quality-of-life (QoL) analyses showed no differences in the functional domains of the relevant questionnaires but the incidence of side effects such as nausea, vomiting and constipation was higher in the RT plus temozolomide arm. Upon disease progression, 39 percent of patients on RT plus temozolomide were able to receive systemic therapy, compared with 41 percent of patients on RT alone.
The study also confirmed that the benefit of temozolomide was greater among patients with O6-methylguanine-methyltransferase (MGMT) promoter methylation. In previous studies, MGMT methylation has been shown to predict a better response to chemotherapy and longer survival in patients with glioblastomas if temozolomide was added to RT. [N Engl J Med 2005;352:997-1003] “In 165 patients with MGMT methylation, the OS for patients receiving combination therapy vs RT alone was 13.5 vs 7.7 months, while the OS in MGMT unmethylated patients was 10.0 vs 7.9 months, respectively,” reported Perry.
“Although glioblastoma disproportionately affects older patients, there are no clear guidelines for treating these patients, and practices very globally,” he remarked. “Our data provide the first evidence from a randomized clinical trial that temzolomide chemotherapy in combination with short-course RT significantly extends survival without detrimental effects to QoL.”
Pembrolizumab, a PD-1 inhibitor, shows activity and an acceptable safety profile in patients with untreated brain metastases due to melanoma or non-small-cell lung cancer (NSCLC).
The non-randomized, open-label, phase II trial included patients aged 18 years or above who were diagnosed with melanoma (n=18) or NSCLC (n=18). All patients had untreated or progressive brain metastases measuring 5-20 mm in diameter without accompanying neurologic symptoms, and were not being given corticosteroids.
The patients received pembrolizumab 10 mg/kg every 2 weeks until disease progression.
Twenty-two percent of patients in the melanoma group and 33 percent in the NSCLC group achieved brain metastasis response. Overall, responses were durable, with all but one NSCLC patient who responded showing an ongoing response at the time of data analysis.
Adverse events reported by patients with NSCLC included grade 3 colitis (n=1), grade 3 pneumonitis (n=1), grade 3 fatigue (n=1), grade 4 hyperkalaemia (n=1), and grade 2 acute kidney injury (n=1).
In the melanoma group, one patient reported grade 3 elevated aminotransferases, while three patients experienced transient grade 3 cognitive dysfunction and grade 1 to 2 seizures.
Results suggested that systemic immunotherapy may have a role in melanoma or NSCLC patients with untreated or progressive brain metastases.
A retrospective analysis of the phase III CALGB/SWOG 80405 trial revealed significant differences in survival and treatment response in patients with metastatic colorectal cancer (CRC) arising in the left vs right side of the colon.
First-line bevacizumab-based treatment was found to be more effective in patients with right-sided primary tumours, while first-line cetuximab-based treatment performed better in those with left-sided primary tumours. [ASCO 2016, abstract 3504]
“While previous studies suggested that tumour location may impact clinical outcomes in CRC, the effect we observed in this analysis appeared to be far greater than what we expected,” said lead investigator Professor Alan Venook of the University of California, San Francisco, CA, US.
The current analysis included 293 patients with KRAS wild-type right-sided primary tumours (caecum to hepatic flexure) and 732 patients with KRAS wild-type left-sided primary tumours (splenic flexure to rectum) from CALGB/SWOG 80405, a trial comparing the efficacy of bevacizumab- and cetuximab-based therapy as first-line treatment in metastatic CRC. [https://clinicaltrials.gov/ct2/show/NCT00265850]
Significantly longer median overall survival (OS) was observed in patients with left- vs right-sided primary tumours (33.3 vs 19.4 months; hazard ratio [HR], 1.55; p<0.0001).
Furthermore, patients with left-sided tumours who received bevacizumab-based treatment had longer OS than their counterparts with right-sided tumours (median, 31.4 vs 24.2 months; HR, 1.32; p=0.01).
“Surprisingly, a big difference in median OS of 19.3 months was observed in those with left- vs right-sided tumours who were randomized to receive cetuximab-based treatment [36.0 vs 16.7 months; HR, 1.87; p<0.0001],” pointed out Venook.
“Cetuximab was more effective than bevacizumab in improving OS in patients with left-sided tumours [HR, 0.82; p=0.01],” he reported. “In contrast, an OS trend favouring bevacizumab was noted in those with right-sided tumours [HR, 1.26; p=0.08].”
“The prognostic and predictive values of left vs right primary tumour location are not something magical. Possible explanations include differences in the distribution of mutations, transcriptional subtypes and hypermethylation,” he suggested. “Embryology may explain these differences – the midgut forms the right colon while the hindgut forms the left colon during embryonic development.”
Another interesting finding was noted in their extpolatory analysis of patients with KRAS mutant tumours. “Although cetuximab is not indicated in KRAS mutant CRC, those with right-sided KRAS mutant tumours who received cetuximab had longer OS than their KRAS wild-type counterparts [median, 23.3 vs 16.7 months],” noted Venook. “If this is eventually confirmed by other studies, we know less about RAS than we think we do.”
“First-line cetuximab and bevacizumab have different treatment effects in subgroups defined by left vs right sidedness of primary tumours,” he concluded. “The study results will influence decisions on treatment sequences, but will not preclude my use of either agent, at least for now.”
Evidence now demonstrates a benefit with 10 years of aromatase inhibitor (AI) therapy in post-menopausal women with hormone receptor (HR)-positive early-stage breast cancer (BC).
Results from the randomized phase III MA.17R trial showed that extending adjuvant letrozole 2.5 mg daily for 5 years after completing an initial 5 years of AI therapy significantly reduced the risk of recurrence by 34 percent (hazard ratio [HR], 0.66; p=0.01) in women with HR-positive BC. After 5 years of follow-up, the rate of disease-free survival (DSF) was improved from 91 percent in patients receiving placebo after 5 years of initial AI therapy to 95 percent in patients who received 5 additional years of letrozole treatment. [ASCO 2016, abstract LBA1]
“Women with early-stage HR-positive BC face an indefinite risk of relapse,” said lead study author Dr. Paul Goss of the Massachusetts General Hospital in Boston, MA, US. “The study provides direction for many patients and their doctors, confirming that prolonging AI therapy can further reduce the risk of BC recurrences. Longer AI therapy also showed a substantial preventive effect in the opposite, healthy breast.”
The trial included 1,918 postmenopausal women who received 5 years of one of three AI therapies with or without prior tamoxifen treatment. The secondary outcome of overall survival (OS) was not improved with extended AI therapy (HR, 0.97), but an improvement was seen in the risk of contralateral BC in the letrozole vs placebo group (0.21 vs 0.49 percent risk;HR, 0.42; p=0.007).
According to Goss, “We expect the curves for DFS to continue to widen over time, demonstrating the persistent benefit of extended letrozole in this subgroup of women. Similarly, we may expect OS curves to widen over time.”
However, with extended AI therapy, bone fractures remain a considerable risk. In the letrozole arm, there were increases in bone fractures (14 percent vs 9 percent with placebo; p=0.001) and new-onset osteoporosis (11 vs 6 percent; p<0.001). It was notable that extended letrozole did not lead to increased toxicities or affect patients’ quality-of-life (QoL).
In a separate analysis of patient-reported QoL in women receiving extended letrozole, no differences in overall QoL or menopause-specific QoL were seen between women who received letrozole or placebo, based on use of the standard SF-36 questionnaire and the MENQOL (menopause-specific quality-of-life) questionnaire. [ASCO 2016, abstract LBA506]
For oncologists, the benefits appear small. Goss too did not advocate extending letrozole treatment in all postmenopausal HR-positive BC patients, suggesting that the decision should be based on discussions between the clinician and the patient.
An interim analysis from the multinational phase III CASTOR trial, presented recently at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that adding daratumumab to the standard two-drug regimen of bortezomib and dexamethasone (Vd) markedly improved outcomes of patients with recurrent or refractory multiple myeloma (RRMM). [ASCO 2016, abstract LBA4]
“Daratumumab is a human CD38 selective monoclonal antibody with direct and indirect anti-myeloma activity that has been approved in the US and Europe for RRMM. It depletes CD38+ immunosuppressive regulatory cells and promotes expansion of cytotoxic and helper T cells,” said lead author Dr. Antonio Palumbo from the University of Torino, in Torino, Italy. “We’ve suspected for a long time that CD38 is the major treatment target for multiple myeloma, but these results are unprecedented in this cancer.”
CASTOR was a multicentre open-label trial that randomized RRMM patients who had received one or more prior lines of therapy to receive daratumumab plus bortezomib and dexamethasone (DVd; n=251) or Vd (n=247) for 8 cycles, followed by daratumumab maintenance in the DVd arm. Baseline demographics and disease characteristics were well balanced between study arms. The primary endpoint was progression-free survival (PFS), with secondary endpoints for response rates, overall survival (OS), time to response and duration of response.
“At a median follow-up of 7.4 months, daratumumab significantly improved PFS, with an unprecedented 61 percent reduction in the risk of progression [p<0.0001]. Median PFS was 7.2 months in the standard treatment arm and not yet reached in the experimental arm,” reported Palumbo. “The estimated 1-year PFS was doubled from 26.9 percent with the standard regimen to 60.7 percent with the addition of daratumumab.”
The PFS benefits of daratumumab were consistent in all patient subgroups regardless of age, disease stage, prior stem cell transplantation or type of prior therapy. “According to the subgroup analysis, patients who had had only one prior line of therapy benefited the most, suggesting that early intervention can maximize the benefit of DVd,” Palumbo emphasized.
Response rates were also significantly improved with daratumumab, including overall response (83 vs 63 percent with Vd, p<0.0001), very good partial response (59 vs 29 percent, p<0.0001) and complete response (19 vs 9 percent, p=0.0012). Time to response was relatively shorter in the DVd arm than in the Vd arm, with about 80 percent of the patients on daratumumab achieving partial response at 1 month.
”Importantly, adding daratumumab does not substantially increase toxicity. The rates of common adverse events such as thrombocytopenia, anaemia, and neutropenia, were only slightly higher in the daratumumab arm,” remarked Palumbo. “Given the encouraging results, this three drug regimen with daratumumab can potentially be considered a new standard of care for RRMM patients.”
A longer follow-up of CASTOR will help to determine the impact of adding daratumumab on patient OS. Ongoing trials are also evaluating daratumumab in combination with another standard therapy for RRMM and testing various daratumumab-based regimens in newly diagnosed multiple myeloma.
The alchemical process of ‘being the change you wish to see in the world’ has a yin and yang (passive and active) component to it. In order to collectively elevate earth we must understand how vital the role of the feminine is in this play.
The presence of the feminine energy has been largely absent from the equation here on earth for some time now. Her power is that of the circle — all encompassing. She is chaos and order, form and formless, both at once. She is non-linear and for this, she can be feared or seen as magic. She is the stillness that births motion and the static from which the ecstatic springs into life.
The feminine energy is here to activate our heart and rise up in balance with the masculine energy to form heart-centered unity consciousness.
The masculine energy is: logic, action, will power, focus, boundaries, intellect, linear.
The feminine energy is: intuition, nurture, compassion, emotions, receptivity, sentience, non-linear.
There must be harmony created between these two forces on an individual level first, in order for it to be available as a living reality on Earth and we are headed in this direction.
We have seen the extent of what a world that is out of balance with its habitat looks like and we have felt the extent of what action without heart can do. When the masculine and feminine forces inside us synthesize together they create heart-centered consciousness, this is where we become the living heart in action.
A mind rooted in the 3rd dimension may perceive turning inward as betrayal to the outside world because our society is heavily production and productivity oriented across the board in all areas of life. We have been trained to intrinsically value what is on the outside while paying little attention to the power that gives birth to the world of form. We go forward on our journey as far as the outside can take us until we realize that the external is an emanation of the condition of our collective psyche and that to place our sole emphasis on changing the outside will only rearrange different versions of the same circumstances we face on all scales of reality.
If our intent is to transmute Earth we will have to become the change we wish to see in all respects of being and not only the outward action based respects. Without internal change we cannot complete the transformation of the individual, thus, the collective. The inner change is where the magic happens.
We are less accustomed to the yin energy. It can be difficult for us to trust in its power as well as uncomfortable to become receptive, open and soft when we have learned to be shutdown and reactionary. When we come from a mind frame of reactivity, we are energetically braced in a stalemate with the state of the world. Our ability to transform the outside is weakened when we become a slave to reacting to it. What is needed is an energy alteration. This alteration comes first through the inner transmutation of the individual.
The feminine force allows us to go inward and open up to receive ourselves at a deeper level. When we travel inward and learn how to nourish ourselves with our own unconditional presence we begin the metamorphosis.
Unconditional presence is the starting point to building unconditional love. If we reach too far too soon, we will overlook true love and mistake it for an endorphin rush. True love is being able to be present with ourselves at our darkest hour. It is about learning how to sit within ourselves no matter what we are going through and fully embrace ourselves in that state consistently and unwaveringly without conditions. When we surrender to ourselves fully, we are sending signals to our heart that we are its keeper, we are safe to be with and that it can stay open.
This daily practice expands our hearts electromagnetic field, which sets off an energetic chain-reaction in our surrounding environment. We begin to generate and share a new coding with the world, one of self-love, connection and care. This love has to be created from within first and not bargained from the outside. This energy emanates stronger in us the more we cultivate unconditional presence and spend more of our time uplifting ourselves and our environment than we are spending in the fear vibration of survival, competition and scarcity where we are energetically overburdened by the weight of the worlds pain and crippled from its frequency rather than altering it.
An illustration of this is similar to a person swimming out in the ocean with the intention of saving someone who is drowning, only to become caught in the same tide and begin drowning next to the very person they were attempting to save. The world needs people who can uplift it without being crushed by its suffering. We elevate humanity by becoming the conscious witness of it and then altering the energy — not spiraling in.
This doesn’t mean that people who are protesting or informing others against the injustices in the world have to stop, what this means is we pay attention to attuning ourselves as an instrument of healing by bringing heart-centered consciousness into our words, actions, and intentions so that we become living portals into a new way of life. Perfection does not need to be reached in order to start making an impact on our environment, in heart-centered consciousness perfection isn’t even a part of the equation, only a willingness to give your heart the respect and attention you have always been worthy of.
Being the change you wish to see in the world has many forms of expression, sometimes it can be as simple as giving someone else the very act of kindness you have yet to receive yourself. Instead of waiting for the world to always meet us where we are at, this reverses the order and allows us to meet the world where it’s at by consciously choosing to bring in a quality that has yet to be experienced, but can still be offered.
The feminine energy is not one of frivolous escapism. She is the essential element—the fundamental puzzle piece inside each of us to birthing a conscious world.
Results from one of the largest pancreatic cancer trials ever conducted may change the standard of care for patients with pancreatic cancer who have undergone surgery.
In the ESPAC-4 (European Study Group on Pancreatic Cancer-4) phase III randomized controlled trial, patients with resected pancreatic ductal adenocarcinoma achieved significant survival benefits with the addition of capecitabine to standard gemcitabine chemotherapy. Patients who received the combination regimen had an estimated 5-year survival rate of 28.8 percent vs 16.3 percent with gemcitabine alone. [ASCO 2016, abstract LBA4006]
The median overall survival was 28.0 months in the combination arm vs 25.5 months in the monotherapy arm (hazard ratio [HR], 0.82; p=0.032).
“The difference in median survival may seem modest, but the improvement in long-term survival is substantial for this cancer,” said Dr. John Neoptolemos of the University of Liverpool, UK, lead author of the trial. “We’ve gone from a 5-year survival rate of 8 percent with surgery alone to nearly 30 percent with adjuvant therapy.”
In the study, 732 patients with pancreatic cancer who had undergone surgery within 12 weeks were randomized to receive either six 4-week cycles of intravenous gemcitabine alone or gemcitabine with oral capecitabine. Patients had a median maximum tumour size of 30 mm, while 42 and 55 percent had a WHO performance status of 0 or 1, respectively. Sixty percent of patients had R1 resections, with 80 percent having node-positive disease and 40 percent having poorly-differentiated tumours.
The patient characteristics were representative of a real-world pancreatic cancer population, with a large proportion of patients having unfavorable prognostic factors. The presence of these factors, however, did not affect the survival benefit seen with the combination regimen.
Patients in the two study arms had similar rates and types of treatment-related serious adverse events (SAEs). In the combination therapy group, 154 SAEs were reported among 24 percent of patients compared with 151 SAEs among 26 percent in the monotherapy group. Rates of severe diarrhea (14 vs 5 patients) and fatigue (16 vs 14 patients) were higher with combination therapy, but patients’ quality of life remained comparable between the two arms.
These findings establish the safety and efficacy of the gemcitabine/capecitabine combination regimen and suggest a potential change in the standard of care for resected pancreatic patients. Currently, gemcitabine is the standard adjuvant treatment for patients with surgically resected pancreatic cancer based on positive results from the ESPAC-1 and ESPAC-3 trials.
Given the improvement in survival with no increased toxicity, the results of ESPAC-4 also suggest an opportunity to add additional treatments to the combination regimen to further improve outcomes.
“Unfortunately, most patients are not candidates for surgery when they are diagnosed with pancreatic cancer,” noted Neoptolemos. “These findings are significant because they show that patients who can undergo surgery have a fighting chance of surviving with the combination of two commonly used chemotherapies.”
The world is slowly but surely turning the page on one of the most fundamental rights we have on this Earth–the right to consume, cultivate and possess a plant. That right has been stripped away from many populations globally for decades. Days after voters in the US state of Ohio rejected a proposal to legalise cannabis for recreational use, Mexico has ruled that pot, whether smoking, consuming or cultivating is a fundamental human right.
The Mexican Supreme Court ruled by 4 to 1 that banning the consumption and cultivation of cannabis for personal use violates the human right to free development of one’s personality.
“This vote by Mexico’s Supreme Court is extraordinary for two reasons,” says Hannah Hetzer of the US Drug Policy Alliance, which campaigns for the relaxation of drug laws. “First, it’s being argued on human-rights grounds, and secondly, it’s taking place in one of the countries that has suffered most from the war on drugs,” she says.
Cannabis reached the United States at the beginning of the 20th century, arriving in the southwest from Mexico, as immigrants fled the country during the Mexican Revolution of 1910-1911. The cultivation of cannabis, commonly known as marijuana, can be traced back at least 12,000 years, which places the plant among humanity’s oldest cultivated crops.However, modern humans have found it acceptable to prohibit the use of one of the most therapeutic plants in the world based on mostly political reasons.
A federal law called the Marijuana Tax Act banned its use and sales in 1937. Prior to 1937 in the United States (and 1928 in the United Kingdom), cannabis had enjoyed a 5,000 year run as a therapeutic plant with no history of illegality.
We now know that accepting and promoting the powerful health benefits of marijuana would instantly cut huge profits geared towards cancer treatment and the U.S. would have to admit it imprisons the population for no cause. Nearly half of all drug arrests in the United States are for marijuana.
Bills to legalise cannabis for medical use are under debate in Brazil, Chile, Colombia and Costa Rica. The world is moving towards it’s inhabitants finally be able to once again possess, sell, transport and cultivate the plant.
Several other countries have moved towards more lenient laws on cannabis use, but none have done so solely on the basis of human rights. Most, like Ireland, which in early November moved towards legalising supervised heroin use and possible decriminalisation of other drugs, have cited health, compassionate and economic grounds.
“We’re seeing a new rationality in relation to drug laws,” says David Nutt of Imperial College London, who is a former UK government adviser on drugs. “At last some countries have the courage to admit that the ‘war on drugs’ is futile and does more harm than good.”
TOP 10 HEALTH BENEFITS OF CANNABIS
Cannabinoids, the active components of marijuana, inhibit tumor growth in laboratory animals, and also kill cancer cells. Western governments have known this for a long time yet they continued to suppress the information so that cannabis prohibition and the profits generated by the drug industry proliferated.
THC that targets cannabinoid receptors CB1 and CB2 is similar in function to endocannabinoids, which are cannabinoids that are naturally produced in the body and activate these receptors. The researchers suggest that THC or other designer agents that activate these receptors might be used in a targeted fashion to treat lung cancer.
2. Tourette’s Syndrome
Tourette’s syndrome is a neurological condition characterized by uncontrollable facial grimaces, tics, and involuntary grunts, snorts and shouts.
Dr. Kirsten Mueller-Vahl of the Hanover Medical College in Germany led a team that investigated the effects of chemicals called cannabinols in 12 adult Tourette’s patients. A single dose of the cannabinol produced a significant reduction in symptoms for several hours compared to placebo, the researchers reported.
Marijuana is a muscle relaxant and has “antispasmodic” qualities that have proven to be a very effective treatment for seizures. There are actually countless cases of people suffering from seizures that have only been able to function better through the use of marijuana.
Since medicinal marijuana was legalized in California, doctors have reported that they have been able to treat more than 300,000 cases of migraines that conventional medicine couldn’t through marijuana.
Marijuana’s treatment of glaucoma has been one of the best documented. There isn’t a single valid study that exists that disproves marijuana’s very powerful and popular effects on glaucoma patients.
6. Multiple Sclerosis
Marijuana’s effects on multiple sclerosis patients became better documented when former talk-show host, Montel Williams began to use pot to treat his MS. Marijuana works to stop the neurological effects and muscle spasms that come from the fatal disease.
7. ADD and ADHD
A well documented USC study done about a year ago showed that marijuana is not only a perfect alternative for Ritalin but treats the disorder without any of the negative side effects of the pharmaceutical.
8. IBS and Crohn’s
Marijuana has shown that it can help with symptoms of the chronic diseases as it stops nausea, abdominal pain, and diarrhea.
Despite what you may have heard about marijuana’s effects on the brain, the Scripps Institute, in 2006, proved that the THC found in marijuana works to prevent Alzheimer’s by blocking the deposits in the brain that cause the disease.
10. Premenstrual Syndrome
Just like marijuana is used to treat IBS, it can be used to treat the cramps and discomfort that causes PMS symptoms. Using marijuana for PMS actually goes all the way back to Queen Victoria.
One of the oldest marketing tricks in the book is to dramatically overprice something in order to increase its perceived value. Ironically, the less intrinsic value the commodity holds, the more effective such a tactic can be. This could explain what’s going on with one of the highest priced and most useless chemotherapy drugs on the market today.
The chemotherapy agent is known as ipilimumab (trade name YERVOY®), and costs about $120,000 for a full course of treatment. While the manufacturer advertises YERVOY® as providing tangible hope to those with non-resectable or metastatic melanoma, it also boldly warns on its website that the effects of this drug can be quite deadly:
What are the serious side effects of YERVOY?
YERVOY can cause serious side effects in many parts of the body which can lead to death. The serious side effects of YERVOY may include intestinal problems (colitis) that can cause tears or holes (perforation) in the intestines; liver problems (hepatitis) that can lead to liver failure; skin problems that can lead to severe skin reaction; nerve problems that can lead to paralysis; hormone gland problems (especially the pituitary, adrenal, and thyroid glands); and eye problems.”
A 2015 report in the Journal of Clinical Oncologyfound that 85% of patients receiving ipilimumab had immune related adverse effects, with 35% requiring systematic corticoidsteroids and 10% anti-tumor necrosis alpha therapy, ostensibly to try to save them from the deleterious effects of the original treatment of ipilimumab. The estimated median time to treatment failure (defined as either the time to new treatment or death) was only 5.7 months.
How could a presumably “immune enhancing” drug that causes the majority to experience severeimmune-related adverse effects including death be advertised to imply that it will confer the possibility of “long-term survival”?
On Bristol-Myers Squibb’s website for YERVOY® the advertising copy reads:
Who wouldn’t want the possibility of long-term survival?
You want more than hope. With YERVOY® (ipilimumab), you have evidence.
What “evidence” supporting YERVOY’s® life-saving power are they referring to? First, let’s look at what ipilmumab actually is.
A Tumor-Derived Monoclonal Antibody For Fighting Tumors?
Ipilimumab (trade name YERVOY®) is part of a class of drugs known as monoclonal antibodies. Monoclonal antibodies are essentially byproducts of a very special type of cancerous growth. They are produced through creating chimeric tumors known as hybridomas. Hybridomas are made by fusing together human myeloma (a type of B-cell cancer) and rodent spleen cells. These biofactories produce monoclonal antibodies which are engineered to attach to specific biostructures/biological targets, though whether they are in actuality as specific in their effects as believed is a matter of question. One of the obvious problems with monoclonal antibodies is that, like most live biological products used to produce vaccines, hybridomas are infected with endogenous retroviruses, which could cause a wide range of health problems.
Is it any wonder that these cancer-cell derived tumors could produce secretions that could lead to harmful effects in the human body?
It is hypothesized that Yevoy supports the anti-cancer activity of cytotoxic T lymphocytes (CTLs) immune system by targeting the CTLA-4 protein receptor, a protein receptor that downregulate the immune system. The theory goes that when the CTLA-4 protein receptor is deactivated through ipilimumab, CTL activity increases, producing a positive effect. This highly linear and simplistic, one cause- one effect logic, has yet to be proven in a convincing manner. One would assume that in the absence of clear proof for a plausible mechanism, the clinical outcomes would speak for themselves, and because the FDA requires placebo-controlled, randomized, double-blind trials, to ascertain efficacy, that this drug would have already been found compelling. Not so.
The “Evidence” That Never Existed
What was the clinical evidence produced by the manufacturer of Yervoy (Bristol-Myers Squibb) to substantiate their claim that it produces, “the possibility of long-term survival”?
In 2007, Bristol-Myers Squibb and Medarex released three studies, one of which showed the drug was incapable of meeting its primary goal of shrinking tumors in at least 10% of the study’s 155 patients.
Even more suspicious is that their phase III clinical studies did not use a true placebo or standard treatment group for their control arm. Instead, the study tested ipilmumab alone, ipilimumab with an experimental vaccine known as gp100, and the vaccine alone.
Although the patients had a slightly higher survival rate with ipilumamab alone (10 versus 6 months), it was not clear whether the experimental vaccine had caused harm, which would have made the drug alone appear to perform better by comparison. The one year survival rate was 46% in those treated with only ipilimumab, compared with 25% in those treated with gp100, and 44% for those receiving both.
A more recent 2015 study published in the American Journal of Clinical Oncology found that ipilmumab produced no increases in survival when added to radiotherapy for melanoma brain metastasis patients, further adding to the evidence against the manufacturer’s claims the drug has been proven to do anything of value for those suffering from cancer.
Unsafe, Not Proven Effective, and 4,000x More Expensive Than Gold
Yervoy is one of the most expensive chemotherapy drugs on the market. In fact, at a 2015 American Society of Clinical Oncology annual meeting, Dr. Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center, discussed the high cost of cancer drugs, citing as an example the cost of ipilimumab (157.46/mg), which is “approximately 4,000 times the cost of gold.” As of 2013 the cost of treatment is approximately $120,000 for a full course.
In a previous essay titled, “Has Drug-Based Medicine Become A Form of Human Sacrifice,” I identified the cancer drug industry’s fundamentally immoral orientation toward cancer treatment, drawing parallels to financial institutions which rely on fiat currencies to accumulate vast power and control:
Turning Disease Into Gold With The Drug-Based Printing Press
Many modern diseases are, in fact, created by fiat (not unlike modern currencies): age-old symptoms of nutritional deficiency or chemical poisoning are repackaged and renamed in Latin and Greek as would-be monolithic disease entities, and subsequently rolled out to the consumer as new markets; each disease representing a veritable gold mine of “treatable” symptoms; each symptom providing justification for the prescription of a new set of patented, toxic drug-commodities.
The “medicines” themselves are often devoid of intrinsic value, being nothing more than rebranded and re-purposed chemicals, intended (though all too often failing) to be administered in sub-lethal concentrations. Indeed, many of these chemicals are too toxic to be legally released into the environment, and should never be administered intentionally to a human who is already sick. You need look no farther than a typical drug package insert to find proof that the side effects of most drugs far outnumber their purported beneficial effects.
These chemicals, in fact, are so highly leveraged against their true value (or lack thereof), that they can sell for as much as 500,000% percent from cost! Only medical/pharmaceutical and financial institutions (e.g. Federal Reserve) are legally empowered to generate the illusion that they are creating something of value out of nothing of value, on this scale. This manipulation of perceived value, which is the basis for the global dominance of the drug-based medical model, is not unlike how financial institutions created toxic derivative products (e.g. Credit Default Swaps), essentially creating the illusion of financial wellbeing and prosperity, at the very moment that they were planting the seeds of death within the global economy; ruining the lives of countless millions in the process.”
Clearly, conventional cancer treatment is not only devastatingly toxic, and may even kill the patient quicker than the cancer they are being treated for, but it can also wreak financial ruin as well.
Humans are social animals. We naturally bond and pair as couples in partnerships and marriage. We live together as families and tribes, and we gather as communities. No doubt this is a manifestation of our spiritual selves which are never alone. This concept has many forms of dress. We call it our connection to God, or with our higher Self, or our oneness with Nature. In some religious traditions, we are all spiritual children of the Creator, or the Great Spirit. In others, as in Kabbalistic traditions, we originate from sparks of one light.
This tradition offers a beautiful illustration of how we are connected to one Source. It tells of a Godhead, an infinite, all permeating light with no beginning or end that filled the entire universe with no empty space. Out of a divine will, the Infinite, contracted Itself unto Itself to create a space where there was only fullness. Ten vessels (Sefirot) were then formed to hold this light. These vessels are said to be filled with the light of ten attributes of how God reveals himself to us, and to Himself. The attributes are:
These attributes may also be viewed as longings we hold as humans. One could argue that these attributes are more easily understood in the context of a relationship than in separateness.
This story beautifully continues that the vessels were not able to hold such emanating light, and shattered. The resulting sparks created souls-the worlds we both know and don’t know, as well as humanity. In a much-oversimplified way, I am explaining that we are created from these sparks of everything, of the Will of God. That we are not alone. And in both physical and spiritual ways we, as humans and as souls, seek to connect with each other. We don’t always do it elegantly, but we are always seeking connection because it is our very nature to be connected.
When we are unable to make this connection, as in consequences of departing from nature, we suffer. The inability to connect causes loneliness, which we are finding has deep implications to our spiritual, mental and physical health.
The following outlines the ways loneliness affects our health:
Predictors of Loneliness
Loneliness is proven to be harmful to our health, and identifying these predictors early can keep us healthier for longer. A recent study, Correlates of social and emotional loneliness in older people: evidence from an English community study, randomly recruited around 1200 adults, aged 65 and older, from a sampling frame and were given a questionnaire to identify the precursors to loneliness. The study resulted in 7.7% of adults feeling severely lonely and 38% of adults were moderately lonely. “Being male, being widowed, low well-being, low self-esteem, low-income comfort, low contact with family, low contact with friends, low activity, low perceived community integration, and receipt of community care were significant predictors of social loneliness.” Identifying how chronic loneliness begins is key in preventing it from affecting your health.
Loneliness and Chronic Illness
Loneliness and Quality of Life in Chronically Ill Rural Older Adults is a study that surveyed 60 chronically ill people face-to-face in determining how loneliness and chronic illness correlate. Using the UCLA loneliness scale and the CASP-12 quality of life scale, the survey examined loneliness and quality of life, and using access to medical records, chronic illness diagnoses, chronic illness control measures, and medication use data were collected. It was found that “participants with a mood disorder such as anxiety or depression had the highest mean loneliness scores, followed by those with lung disease and those with heart disease. Furthermore, participants with mood disorders, lung disease, or heart disease had significantly higher loneliness scores than those without these conditions. Loneliness was significantly related to total number of chronic illnesses.”
The study concluded nurses should assess patients with chronic illnesses for loneliness. The findings found loneliness to be a significant issue in rural, older adults, especially those who suffer with mood disorders, heart disease and lung disease.
Loneliness and Blood Pressure
70 million Americans struggle with high blood pressure each year, and the fact that loneliness affects blood pressure proves that socialization is truly beneficial for your health. Loneliness Predicts Increased Blood Pressure: Five-Year Cross-Lagged Analyses in Middle-Aged and Older Adults tested a multiracial group of 229 people for five years. The analyzed panel revealed that “loneliness at study onset predicted increases in [systolic blood pressure] 2, 3, and 4 years later. These increases were cumulative such that higher initial levels of loneliness were associated with greater increases in SBP over a 4-year period.” The study found that loneliness did not have a significant short-term effect on SBP, but loneliness was revealed to have a strong, obvious influence in larger increases of SBP over a four year period. A simple assessment of loneliness by questionnaire or interview could be sufficient to determine whether the patient should be referred to a clinical psychologist for therapy. Loneliness and high blood pressure have been known to increase mortality rates; however, simply decreasing loneliness in our day-to-day lives will keep us healthy and lengthen our life spans.
Loneliness and Fibromyalgia
Conducted last year, Loneliness, Daily Pain, and Perceptions of Interpersonal Events in Adults with Fibromyalgia examined loneliness and its effects on patients with fibromyalgia. This study observed whether individual differences in loneliness and/or daily exacerbations in loneliness relate to daily pain and frequency among people with fibromyalgia. 118 participants with fibromyalgia completed journals each evening for 21 days to assess the amount of positive and negative interpersonal events, event assessments, and pain. The reading concluded that “chronic and transitory loneliness were associated with more frequent reports of negative and less frequent reports of positive interpersonal daily events, higher daily stress ratings and lower daily enjoyment ratings, and higher daily pain levels.” Ultimately, the chronic and temporary episodes of loneliness are associated with more negative daily social relations and pain. Boosts in positive events were found to be like interventions for those with chronic pain.
Loneliness and Death
A newly published study, Loneliness and Mortality Among Older Adults in China, used data from a nationally representative sample of 14,072 adults aged 65 and older from the 2002, 2005, and 2008 waves of the Chinese Longitudinal Healthy Longevity Survey to examine the relationships between loneliness and mortality. Ye Luo, author of the study, wrote, “About 28% of older Chinese adults reported feeling lonely, and lonely adults faced increased risks of dying over the subsequent years.
Loneliness both affects and is affected by social activities, solitary leisure activities, physical exercise, emotional health, self-rated health, and functional limitations over a 3-year period.” The study discovered that after taking social relationships into account, those with higher levels of loneliness tend to die earlier than those with lower levels. Behavioral and health outcomes at least moderately facilitate the effect of loneliness on mortality among older Chinese adults as we see attenuations of the direct effect of loneliness on death once behavioral and health variables were added.
In addition, a meta-analytic review was conducted to determine the extent to which social relationships influence risk for mortality. Social Relationships and Mortality Risk: A Meta-analytic Review found that across 148 studies, there was a “50% increased likelihood of survival for participants with stronger social relationships…and the association was strongest for complex measures of social integration.” The analysis indicates that the influence of social relationships on the risk of death are not only comparable, but exceed, well-established risk factors for mortality-such as smoking, alcohol consumption, physical inactivity and obesity. The fact that loneliness is just as detrimental to our health as smoking and other dangerous activities illustrates how vital connection and companionship is, and why we crave it on such a fundamental level.
Separateness Equals Dis-ease
Loneliness is just one way that our environment can affect our biology. Our thoughts and emotions influence our health in many ways at a deep and cellular level. As many traditions suggest, we all originate from and connect to a life-source. In naturopathic medicine , which views the mind and body as inseparable, this is called the “Vis”, or Vital Force, which is the innate healing energy that propels us toward homeostasis and health; towards life!
A separation from each other is a separation from our selves and from our very life source. Loneliness and connection are as important factors of health as good nutrition or any tangible risk factor for disease.