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Sayer Ji, Founder
March 20, 2016
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 Oncology found 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 severe immune-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.1
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.2
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