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Miscommunication of Toxicity of Drugs in Clinical Trials

Feb 4, 2020

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Reporting of clinical trial results of cytotoxic chemotherapy drugs downplay the harmfulness and toxicities of the drugs through milder and often misleading descriptions. Studies in which the drug was said to be well tolerated have reported over a third of the patients discontinuing the drug due to severe adverse events. Miscommunication of drug toxicity should be avoided and potential side-effects of drugs should be reported accurately.

Have you ever seen a commercial for a new drug that has come to market that is full of happy people during the commercial and then in the end, because the drug companies are legally obligated to do so, a really fast and low pitched voice reads out a scary list of side effects which almost always ends with potential death? Obviously, the drug companies are going to try to downplay any potential side effects their drugs may cause even if, and in many cases this is true, the side effects may be worse than the original problem the drugs are trying to fix. Similarly, many clinical trials use language that is not entirely descriptive of the potential toxicity (leading to miscommunication) and side effects of prescribed chemotherapy drugs.

Miscommunication of Toxicity of Drugs in Clinical Trials

The reason why the harmfulness of the drug toxicities gets downplayed towards a potential patient is simply because of the misleading and overly encompassing language used by pharma companies. And to sound the alarm to fellow physicians and clinical researchers on the problem, medical researchers from the Massachusetts General Hospital in Boston published an article in the New England Journal of Medicine. In this article, they found that clinical trials will often describe the side effects of chemo drugs as ‘manageable,’ ‘safe and effective’ or ‘generally well tolerated’ when none of these are even close to fully describing the scope of the problem. For example, in a colorectal cancer study between two groups that was deemed to be ‘well tolerated,’ “adverse events led to discontinuation of chemotherapy in 39% of patients in one treatment group and 27% in the other. In total, 13 people died from an adverse event” (Chana A. Sacks et al, N ENGL J MED., 2019). Putting such a mild label on a drug whose toxicities literally caused some people to die is simply wrong. The effect on one’s quality of life is still being explored by countless studies but the bottom line is that clinical studies need a new approach in how they are going to inform potential users and physicians about the potential side effects of their drug.

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Regorafenib as an example of drug with significant toxicities

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Regorafenib is a targeted cancer drug that has been approved by the FDA to treat metastatic colorectal cancer only if patients have failed several other chemotherapy types such as OXA, fluoropyridine, IRN based chemotherapies and anti-VEGF therapy. A drug like Regorafenib was associated with significant toxicities at the approved doses, which mandated a reassessment of its dosing schedule and toxicity profile post approval. So even though this drug has been proven to be effective in terms of its ability to eradicate tumors, physicians have to be extremely cautious in both delivering doses and informing patients of the potential toxicities that come with taking such a drug. In a study by medical researchers from Columbia University in New York on the efficacy and potential effects of Regorafenib, a GRID trial was done enrolling 199 subjects who each took 160mg of Regorafenib orally for 3 out of 4 weeks each cycle and adverse effects were reported in 98% of patients and “the most common adverse reactions reported were hand foot skin reactions (56%), hypertension (48.5%), diarrhea (40%) and fatigue (38.6%)” (Demetri GD et al, Lancet, 2013; Krishnamoorthy SK et al, Therap Adv Gastroenterol., 2015). On top of this, there was significant skin damage on one’s hands also reported by patients.

The bottom line is that patients need to know what they are getting into and this cannot be possible if they are misled by intentional or unintentional broad wording (miscommunication) that fails to accurately describe the potential problems such as toxicity, that such drugs could lead to.

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Scientifically Reviewed by: Dr. Cogle

Christopher R. Cogle, M.D. is a tenured professor at the University of Florida, Chief Medical Officer of Florida Medicaid, and Director of the Florida Health Policy Leadership Academy at the Bob Graham Center for Public Service.

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