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It is a smart survival strategy to be properly informed before committing to drug-based immunotherapies (immune therapy) therapies: For example –  do you know about…

*The potential severity of side effects – severe organ damage etc.
*The USA litigation cases re harm from many drug based immune therapies such as Keytruda.

Background: There is much excitement & euphoria in the media & medical journals about the new drug-based immune therapies. Oncologists worldwide have been motivated by convincing pharmaceutical company literature with stories of spectacular remissions that have occurred. 

Consequently; there are now many clinical trials available for various types of immunotherapy – the number is increasing. Some patients have been able to afford these very expensive drugs. 

These drugs are Keytruda, (Pembrolizumab), Optivoy, (Nivolumab) Yervoy (Ipilimumab)  (collectively called antiPD1 therapies) plus the newer CAR-T CELL therapy. More are in the pipeline. 

Similarly; patients are excited about drug-based immune therapies thinking it is a more natural way for cancer treatment & safer than chemotherapy. They have even been told it is personalised medicine – in reality – its not.

SOME SIDE EFFECTS OF DRUG BASED IMMUNOTHERAPIES

While the euphoria continues to grip oncologists in Australia and New Zealand, the euphoric dust has settled in the USA & Europe where they are now treating these new drugs with CAUTION.

Warnings are cropping up in the medical literature detailing severe & unpredictable side effects caused by drug based immune therapies. Deaths have been reported & long-term (unpredictable) side effects have been severe. Drs have been told to issue patients with medical alert cards in case they end up in intensive care or emergency wards.

There have been numerous court cases. Even the FDA is being sued. BUT: Australia and New Zealand lag behind the US and Europe.

Consequently: Doctors in Australia and New Zealand are still enthusiastically prescribing drug based immune therapies (and not issuing medical alert cards to them as they do in the US).

It would be tragic for patients in AU & NZ to experience severe side-effects and or death, knowing that in some years time our doctors, doctors here, like their counterparts in the US, will become  more informed & cautious about prescribing drug based immune therapies.

Therefore; we advise you to read on & become better informed – especially read about the medical litigations.

Do your own research.
See – Keytruda Litigation Controversies 

WHY IT IS CRUCIAL TO BE INFORMED!

We know that cancer patients are interested in the most effective & most minimally invasive cancer treatments. BUT knowledge and a dash of caution is required before considering taking treatment with a drug-based immune therapy.

While there have been both short and long-term successes in treating melanomas; some kidney cancers & some lung cancers; it is important patients are aware of the risks.

The most common procedure for CAR-T cell therapy starts with the extraction of T cells from the own patient. The T cells are then genetically modified to express a CAR and expanded in the Laboratory.

Finally, they are re-infused into the patient, ready to fight the tumour. Unlike the unblocking effect of the immune system to find and destroy cancers; immunotherapies based on CAR-T cells go one step further by engineering the T cells themselves to enhance the response from the immune system against a specific tumour antigen.

The flip side of the benefit of drug-based immunotherapy, which is a long-term response against the cancer, is that toxicities can happen at the beginning of treatment or long after their last dose.” (GGI Note: up to 4 years later) Sandip P. Patel, MD (ASCO Post – American Society of Clinical Oncology) 

Please read on & inform yourself about the difference between drug based immune therapy & cell based immune therapy (immune therapy made from components of your own immune system). See also – Safe Immune Therapies

NO MORE GUESSWORK: A BRILLIANT NEW GENOMIC TEST CAN GAUGE YOUR SUITABILITY FOR A DRUG-BASED IMMUNOTHERAPY - NO MORE NEED TO SUFFER WITHOUT GAIN - READ ON

BE INFORMED- DO KNOW THERE IS A NEW TEST THAT ELIMINATES GUESSWORK (& ANXIETY):

There is a now test for measuring your suitability for drug based immune therapies:  Most patients are not informed that the test;  Tumour Mutational Load (TML) – is available & performed at genomic diagnostic laboratories. 

This test can give patients and their oncologists a particular measurement, that indicates whether or not a drug based immune therapy will work for you (popularly known as anti-PD1 immune therapy).

SADLY: It is unlikely the test will be offered to you by hospitals in AU & NZ. 

Contact us today for more information about this new test.

We are playing with fire,” said Dr. John Timmerman, an oncologist and immunotherapy researcher at the University of California, Los Angeles, who recently lost a patient to side effects.

The woman’s immunotherapy drugs had successfully “melted away” her cancer, he said, but some weeks later, she got cold and flulike symptoms and died in the emergency room from an inflammatory response.

Dr. Timmerman described it as “a mass riot, an uprising” of her immune system – Immune System, Unleashed by Cancer Therapies, Can Attack Organs 

The links below (purple) are from reputable medical resources: 

Patients treated for skin or lung cancer cancer using newer, potent immunotherapies appeared to be at an increased risk of developing thyroid-related adverse events, researchers reported here. Of 93 patients treated with pembrolizumab (Keytruda), 14 developed thyroid dysfunction.  These drugs release the brakes on the immune system, and by releasing those brakes, of course, you can get autoimmune diseases. It can cause problems with the colon; it can be the liver; it can be the thyroid.”

Cabanillas said that the Mayo researchers are reporting on thyroiditis with pembrolizumab “which is usually what we see with this class of checkpoint inhibitors but there are other types of checkpoint inhibitors, such as ipilimumab, [that]…cause more pituitary adverse events.” Solid Tumor Immunotherapy May Impact Thyroid

Despite the optimism, though, it’s important to know that CAR T-cell therapy has significant downsides: It’s not available to most patients, its approvals have strict limitations, and it often triggers serious side effects in some patients. Five things you should know about CAR T-cell therapy
Cancer Treatment Centres of America, (CTCA), March 20, 2018


Immune-based therapies in oncology present challenges in recognising & managing treatment-related toxic effects. Although many oncologists know of their adverse-effect profile, treatment remains limited to specialised centres with experienced & highly-skilled clinical care teams, capable of providing the supportive care required for patients undergoing such therapy, owing to the risk of severe hypotension and organ failure during treatment. Managing the Side Effects of Novel Cancer Immunotherapeutics


The toxicities of immunotherapy for cancer are as diverse as the type of treatments that have been devised. These range from cytokine therapies that induce capillary leakage to vaccines associated with low levels of autoimmunity to cell therapies that can induce damaging cross-reactivity with normal tissue to checkpoint protein inhibitors that induce immune-related adverse events that are autoinflammatory in nature. Toxicities of Immunotherapy for the Practitioner

During the last years several cases of fatal heart failure have been documented in melanoma patients treated with checkpoint inhibitors. Checkpoint Inhibitors & Cardiac Toxicity: An Emerging Issue 


ASCO – Although (drug-based) immunotherapies can be effective in boosting the body’s natural defence against cancer in some patients, providing durable remissions in a small percentage of cases, they can also result in myriad immune-related adverse events due to misdirected stimulation of the immune system. E.G. only a small percentage of patients—between 15% and 20%—receive some benefit from checkpoint inhibitors that target CTLA-4 or the PD-1 and PD-L1 pathways for the majority of tumor types. They can also cause immune-related adverse events in which the immune system starts attacking normal tissue – some patients experience the side effects and none of the benefit. ASCO – Meeting the Challenges of (drug-based) Immunotherapy-Related Toxicities


Dangers with Car T Cell therapies – the popular new immune treatment 

Car T Cell therapies – worrisome, and sometimes fatal, side effects –  e.g. cytokine-release syndrome (CRS)

Car T Cell Therapies – Revolutionary new cancer therapies come with big risks. Drug makers must be prepared 


Sudden severe side effects – it can take a small army of top specialists to keep patients alive while their newly engineered immune systems attack their cancer cells. Remains so risky, so complex, so difficult to manage that experts warn it’ll be years… –  Car T Cell Therapies 


Keytruda immunotherapy deaths higher than control group.The decision was taken after independent safety monitors observed more deaths in patients receiving the Keytruda combination than in the control groups in two of the studies… FDA stops Merck Trial 


Cytokine release syndrome (CRS)  The hallmark of CRS is immune activation resulting in elevated inflammatory cytokines. Clinical and laboratory measures range from mild CRS (constitutional symptoms and/or grade-2 organ toxicity) to severe CRS (sCRS; grade ≥3 organ toxicity, aggressive clinical intervention, and/or potentially life threatening). Clinical features include: high fever, malaise, fatigue, myalgia, nausea, anorexia, tachycardia/hypotension, capillary leak, cardiac dysfunction, renal impairment, hepatic failure, and disseminated intravascular coagulation – often requiring treatment in ICU… Toxicities of CAR T-Cell Therapy 

Financial Costs of Drug Based Immune Therapies

According to a research letter published in JAMA Oncology, patients treated with CAR T-cell therapy will incur on average $30,000 to $36,000 (USD) in additional costs aside from drug expenses. (e.g. $500/dose) 

Patients who present with side effects from severe cytokine release syndrome may pay up to $56,000 (USD) more

Read More
      

“To our knowledge, this study provides the first estimates of the total costs of chimeric antigen receptor [CAR] T-cell immunotherapies in the United States,” Inmaculada Hernandez, PharmD, PhD, assistant professor of pharmacy and therapeutics at University of Pittsburgh, and colleagues wrote
Last year, FDA approved the first two CAR T-cell therapies.
Tisagenlecleucel (Kymriah, Novartis) is approved for treatment of patients aged up to 25 years with refractory B-cell precursor acute lymphoblastic leukemia, as well as those whose disease is in second or later relapse.
Axicabtagene ciloleucel (Yescarta, Kite Pharma) is approved for adults with relapsed or refractory large B-cell lymphoma who underwent two or more lines of systemic therapy.

Treatment with tisagenlecleucel has been priced at $475,000 and axicabtagene ciloleucel has been priced at $373,000. However, these prices do not account for costs associated with treatment, including hospital stays and treatment for related toxicities”. Source: Healio