CANCER AND CARDIOVASCULAR DRUG TRIALS……
SPIN, MISREPRESENT, LIE
“A growing body of literature has documented the prevalence of these lapses in fields as diverse as radiology, cancer biomarkers, and diagnostic testing, not to mention basic sciences.” From the editorial being discussed today
“You break the laws. You hustle, you deal, you steal from us all.” AC/DC from 1990’s Money Talks Just last week, a couple of telling studies were published in the Journal of the American Medical Association — Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration and Level and Prevalence of Spin in Published Cardiovascular Randomized Clinical Trial Reports With Statistically Nonsignificant Primary Outcomes. Before breaking these studies down with you, realize that my title was essentially taken from the studies themselves. Also realize that cancer and cardiovascular disease have been running neck-and-neck, vying for first place on the death-rate chart, with cancer recently taking over the lead.
American cancer treatment is a money-making machine — a veritable gold mine. The American Journal of Managed Care (The Economics of Cancer Care in the United States) recently stated that “Between 1990 and 2009, estimated adjusted annual direct medical spending on cancer in the United States doubled. During 2010, the United States spent an estimated $125 billion on cancer care.” The thing is, that was a decade ago, and costs have skyrocketed since then. Three years ago next month, Meg Tirrell wrote an article for CNBC (The World Spent this Much on Cancer Drugs Last Year) shedding light on the fact that the US using the biggest portion of the world’s supply of cancer drugs. “Spending on cancer medicines is projected to exceed $150 billion by 2020.” A report on cancer spending from The IQVIA Institute for Human Data Science said that from 2016 to 2017 — a single year — the cost of a new cancer drug went from an average of $100,000 to $150,000, with that expected to double by 2022. No matter how you slice it, AMERICAN CANCER is out of control.
Rather than focus on cost here, let’s ask the question, ‘what are we getting for our money?’ According to the first study mentioned above, not much. Let’s take a look at what this team of four researchers from Mayo Clinic and Oregon Health & Science University had to say. After looking at “145 studies that led to 143 drug approvals,” the authors showed that over the course of the past five years, both the medical community at large and the general public are being hoodwinked by yet another of the many “TRICKS OF THE TRADE“. It seems that in a whopping 2/3 of the studies observed, the control group was, “inferior to other available agents, or the trials did not allow standard of care combinations of agents to be used.” In other words, researchers routinely and purposefully tested new drugs against drugs that were known to be inferior to other drugs currently being used. And this was just for starters — there several different methods researchers were accomplishing this. “Although anticancer drug approvals are increasing, a proportion of these drugs are reaching the market without proven superiority to what is considered the standard of care.” None too comforting for those who choose to make chemotherapy a part of their CANCER-FIGHTING PROTOCOL.
Let’s now turn our attention to the second study on drugs for cardiovascular diseases. The team of ten authors, from a Who’s Who of public and private universities and facilities (Duke, Creighton, Cleveland Clinic, Mayo, etc, etc), compared reported research findings concerning brand new cardiovascular drugs to the research itself, asking the question, “Do authors of cardiovascular randomized clinical trials (RCT’s) present statistically non-significant primary outcomes accurately and objectively?” After reviewing almost 100 trials from six of what could arguably be called the most prestigious journals for publishing cancer research in the world, they came to these CHERRY-PICKED conclusions…..
“Clinical researchers are obligated to present results objectively and accurately to ensure readers are not misled. In studies in which primary end points are not statistically significant, placing a spin, defined as the manipulation of language to potentially mislead readers from the likely truth of the results, can distract the reader and lead to misinterpretation and misapplication of the findings. Positive spin of statistically non-significant primary outcomes was found in 57% of abstracts and 67% of main text of the published articles. manipulation of language in the cardiovascular literature is common. investigators often manipulate the language of the report to detract from the neutral primary outcomes. To best apply evidence to patient care, consumers of cardiovascular research should be aware that peer review does not always preclude the use of misleading language in scientific articles. Our results align well with findings of spin in reports from other medical areas.”
In other words, “SPIN” not the exception, it’s the norm. Interestingly, JAMA also carried an editorial on the topic by one Stephan Fihn, an MD and public health expert from the University of Washington (Combating Misrepresentation of Research Findings). His piece was interesting in an of itself because it was both a criticism (his article provided nine different bullet points of different ways experts are “misrepresenting” the research) as well as a defense of the profession as a whole. “We make every effort to embrace well-founded, negative findings as avidly as positive ones. Although negative trials typically do not attract as much attention, they are often critically important in countering erroneous inferences from earlier studies or debunking widely held misconceptions.“
While this last quote above has a modicum of truth to it (negative findings don’t attract a lot of attention), suffice it to say that there is enough falsehood present to cast doubt on the entire medical research field. How so? It’s important to realize that in at least 50% of all biomedical research, negative findings are not only not being reported, they are being buried in hopes they never see the light of day. This is not only an easy (and cheesy) way to create the specific findings you or the people funding said research are looking for, it’s how I came to be the reigning world-record holder for consecutively made free throws (THAT’S RIGHT, I DON’T COUNT MY MISSES). It all has to do with a phenomenon so common in the medical research community that it has its own name — INVISIBLE & ABANDONED, and happens to be a prime reason both doctors and patients are bailing on their trust of oxymoronically-named EVIDENCE-BASED MEDICINE.
Want to help yourself? Interested in diminishing inflammation, getting to an optimal weight, and taking charge of your health? Then you’ll have to do a chunk of it yourself. HERE IS A STARTING POINT. Nope; it’s not a solution for every person or every situation. However, it should get most of you thinking outside the box — the place where true healing is occuring in our modern era. Oh; don’t forget to like, share or follow on FACEBOOK if you appreciate information like this, as it’s still a nice way to reach the people you love and value most.