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Clinical Trials are misleading- in my experience anyway. I say this because I have been reading articles, synopses, etc. about clinical trials since I reached complete remission from my own cancer in 1999. And what I have found is, as a general rule, clinical trial write-ups underplay adverse events aka side effects.
My point is that my years of experience point to exactly what the authors of the paper linked below are also saying.
Why does this matter?
Oncologists make many of their treatment decisions based on clinical trial data. Newly diagnosed cancer patients also make decisions about their treatment based on clinical trial data. So when a study says that “side effects are manageable” the patient may does not consider the risk of death, for example, if they undergo the particular chemo regimen. Even if patients died during the clinical trail.
No therapy or combination of therapies can be prescribed by oncology without the Food and Drug Administration’s approval of that therapy. This is the way that conventional oncology works in the United State. This process if fine in my opinion.
My problem with the FDA’s approval process of chemotherapy regimens is that the FDA pronounces therapies to be “safe and effective.”
I can speak only about my own personal cancer therapy experiences. I underwent 6 courses of a chemotherapy triplet (VAD), two courses of high dose cytoxan (cyclophosphamide) and an autologous stem cell transplant. All of these therapies were labeled safe and effective by the FDA.
I relapsed in less than 12 months post ASCT, reached end-stage a year and a half later and was told by my oncologist that they could do nothing more for me.
This entire conventional treatment process cost me and my health insurance provider, Medical Mutual more than $250.000. Since that time I’ve developed a series of long-term and late stage side effects.
I don’t mean to sound whiney but I live life in constant pain. Due to safe and effective therapies that my board-certified oncologist prescribed. That didn’t work. That cost a small fortune.
What does this mean for the newly diagnosed cancer patient?
Newly diagnosed cancer patients, generally speaking, are scared, bewildered, angry or a combination of these negative feelings. Newly diagnosed cancer patients don’t know what they don’t know. Patients must be able to trust their oncology team to give them the straight-scoop about their cancer treatments.
At the same time, cancer patients must learn about those therapies that conventional oncology does not. Evidence-based but non-conventional therapies such as nutrition, supplementation and other complementary therapies.
Cancer patients don’t know what they don’t know. Their doctors as well as clinical trial data is supposed to help them understand…
Have you been diagnosed with cancer? In addition to talking to your oncologist, consider also talking to a long-term cancer survivor about the pros and cons of conventional oncology. Get the straight-scoop.
Hang in there,
“Abstracts of randomized phase 3 clinical trials in gastrointestinal oncology frequently use subjective minimizing language to characterize serious toxicities, according to results of a systematic review presented at ASCO Annual Meeting…
“The argument that we made in this paper is that we should consider no longer using these terms and instead report objective metrics,”
“For example, instead of saying a treatment is ‘well-tolerated,’ we should say that 30% of patients had serious adverse events,” Gyawali added. “If we want to use these terms for the sake of great abstracts, then we should start collecting that data…”
Gyawali and colleagues — including Nicole M. Kuderer, MD, MS, FASCO, faculty member in the department of medicine at University of Washington — reviewed abstracts of 63 randomized phase 3 clinical trials…
They determined 15 (24%) of those abstracts used “any subjective minimizing language” and that 60 (95%) of them used subjective or objective toxicity minimization. Information about serious adverse events also is frequently absent or incomplete, investigators concluded…
Dr. Gyawali: I published a paper in 2018 in The BMJ that looked into how clinical trials use subjective minimization terms to downplay risks for toxicity. I highlighted certain terms — such as “tolerable,” “manageable” or “acceptable” — that often were used subjectively to describe harms in cancer clinical trials. Some of the findings were very surprising.
In one trial, toxicities were described as “manageable,” but several patients died of adverse events. If a patient died, by definition, it is not manageable…
“US researchers have claimed that most randomised trials of new treatments published in leading medical journals are reported in a potentially misleading way, with statistics designed to make the results more positive than if other statistical tests were used.
Researchers from the University of California at Davis, near Sacramento, reviewed 359 randomised clinical trials of new treatments published between 1989 and 1998 in five major medical journals: the Annals of Internal Medicine, BMJ, JAMA, Lancet, and New England Journal of Medicine.
They found that most of the trials report results based on relative risk reduction—the percentage difference in end points between the active treatment and the placebo or comparison treatment. The study showed that only 18 of the papers reviewed considered absolute risk reduction—the actual difference between the treatment and placebo results. Only eight of the 359 trials reported the number needed to treat—the number of patients needed to be treated with a drug to prevent one adverse outcome, for example a myocardial infarction (JAMA 5June 2002)…”