Immune checkpoint cancer therapies may cause rare cardiac side effects

by , under Big Pharma, Contemporary Cancer Topics, Conventional Treatments, The Cancer Industry

Despite all of the hoopla about immunotherapy being the latest ‘game changer’, once again we witness the harmful side effects of another cancer treatment method being strongly pushed by Big Pharma.

Immunotherapy is being touted as the latest miracle method of beating cancer. Unfortunately, it appears that this particular method is not as deadly as chemotherapy and radiation, but there are still dangers. It would appear that they need to do more study of this one so that they don’t damage people’s hearts with it. They say that immunotherapy is effective in about 25-33% of patients.

A huge problem with immunotherapy is that the average price for treatment is about $100,000/year. It’s a huge expense to patients and the healthcare industry, and the country.

The story never changes. The only strategies that Big Pharma appears to like are the ones that have some sort of harmful effects on the human body. Actually using something that is harmful to cancer and good for the body isn’t on the ‘playlist.’  The problem is that most substances that aren’t harmful to your body are usually not able to be patented so Big Pharma businesses would not be interested in anything like that. No profits-no chance of being used. And if you think about it, they would actively go out of their way to suppress and get rid of anything that would destroy profits of their drugs. And they do

When will people finally start to realize that businesses exist to make profit? When you tie profits into health care, the well being of the patients is going to be secondary to the profit motive. Yes all these people involved in health care and cancer have families and friends that come down with cancer, but they still have a duty to answer to the profit motive. And that’s exactly what most of them do. Unfortunately, financial concerns usually have a higher priority than what is best for the patient. It’s a lot to ask one person to take on the entire Medical Establishment and risk their livelihood.

Why do you think that Big Pharma doesn’t fund ANY research of natural (non-toxic) treatments for most diseases? Because if their strategy was really to cure cancer and other diseases, it wouldn’t take this long to find something more effective than what they’re doing already. Part of it is that the FDA has a huge barrier to entry with the average drug study costing $800 million to conduct. How’s that for a barrier to entry?

And worse yet, why do you think that everything they allegedly study that is non-toxic or non-patentable ends up as ‘there is no evidence that [insert cheap natural effective substance here] has any effect on [insert Big Pharma disease here]?’ Aren’t you curious about why the only effective treatments for any disease are profitable for Big Pharma? Every single time? Even though they scour the plant kingdom for effective molecules they can patent at a feverish rate?

What I do know is that if a natural treatment was killing patients or causing fatal cardiac side effects, it would be all over the mainstream news and they’d be accusing the practitioners of being dangerous quacks and would be clamoring for their imprisonment. But it’s ok if they kill patients with drugs because that’s the approved method of treating patients. That’s what we are told is objective ‘science.’  And the body count continues to rise…

For more information, here are some of the best alternative cancer web sites you can find to get yourself educated!

(bold type emphasis is mine)

Combination therapy utilizing two approved immunotherapy drugs for cancer treatment may cause rare and sometimes fatal cardiac side effects linked to an unexpected immune response.

In a study led by Vanderbilt University Medical Center (VUMC) investigators and published in the Nov. 3 issue of The New England Journal of Medicine, researchers describe two cases of acute and unexpected fatal myocarditis (inflammation of the heart muscle) that occurred in melanoma patients following treatment with a combination of ipilimumab and nivolumab.

Both drugs are FDA-approved immune checkpoint inhibitors which stimulate an anti-tumor response in cancer patients. Ipilimumab is an anti-cytotoxic T-lymphocyte- associated antigen 4 (CTLA-4) antibody, and nivolumab, an anti-programmed death-1 (PD-1) antibody.

The use of these immune checkpoint inhibitors, especially in combination using two such therapies, has enhanced the treatment of several types of malignancy.

Common side effects of these agents such as inflammation of the skin, colon, liver, endocrine glands and lung, are thought to arise from off-target activation of T cells in the immune system.

In the two study cases, a 65-year-old woman and a 63-year-old man, both with metastatic melanoma, were hospitalized nearly two weeks after initiation of the combination therapy.

Javid Moslehi, M.D., assistant professor of Medicine, director of the Cardio-Oncology Program at VUMC and corresponding author of the study, said both patients had seemingly mild symptoms at the time of hospitalization.

“The patients came with rather vague symptoms including fatigue and muscle aches. What made us take notice, however, were blood tests for cardiac damage that were extremely elevated and the electrocardiograms (EKG) that were abnormal in both cases. The problems quickly advanced such that the patients each needed a pacemaker to control the heart’s electrical activity. The degree of cardiac arrhythmia was striking,” Moslehi explained.

“Even aggressive combinations of these immune therapies are usually well tolerated with very selective activity against the tumor instead of self,” said study first author Douglas Johnson, M.D., M.S.C.I., assistant professor of Medicine and clinical director of Melanoma. “But we occasionally observe these cases of wildly dysregulated autoimmune activation.”

Johnson said VUMC physicians quickly treated the patients with high-dose corticosteroids (methylprednisolone). Despite aggressive treatment, both patients died from myocarditis.

The two similar cases stimulated a cross-disciplinary effort at VUMC to investigate the mechanisms of toxicity and potential treatments for patients with such rare reactions. The investigators collaborated with colleagues at Harvard Medical School, Johns Hopkins School of Medicine, and Bristol-Myers Squibb, the company that makes both drugs.

Justin Balko, Pharm.D., Ph.D., assistant professor of Medicine and Cancer Biology and leader of Molecular Oncology in the Center for Cancer Targeted Therapies at Vanderbilt-Ingram Cancer Center (VICC), said on autopsy and biopsy of the cardiac tissue it was clear that there was an immune reaction to the heart. VUMC pathologists found robust T cell and macrophage infiltrates. Importantly, there were shared populations of T cells infiltrating the myocardium which were identical to those present in tumor and skeletal muscle.

“One hypothesis based on the data is that essentially the body is seeing the heart and muscle tissue as foreign, just like the tumor,” Balko said. “This gives us a starting point to develop a model to see how consistent this is with other cases as they appear and once we have that model, determine the right way to intervene so that we can keep other patients safe.”

Study authors said global data reveal that myocarditis has occurred in less than one percent of patients treated with the ipilimumab/nivolumab combination therapy to date, suggesting this is a rare, potentially fatal T cell-driven drug reaction.

Johnson suggested “presumably the treatment strategy would involve high-dose steroids and possibly other intensive immune-suppressive drugs, as well. The best regimen is unclear at this point.”

Leave a Reply