thinking about side effects

Thinking About Side Effects

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I have been thinking a lot about how we characterize the side effects of drugs. Truth be told, that is a topic that I have pondered on a number occasions since beginning this website. More often than not, we have no idea about the true breadth and depth of these reactions. We think we do, because assuming some semblance of understanding, even an incomplete one, is what allows us operate in this space, but when we unpeel the layers of that supposed understanding, it is difficult not to be impressed by how little we actually know.

The manufacturers of these products are required to report adverse reactions and side effects before a drug reaches the market and surveil reactions in the broader population after it reaches the market. From here, regulatory agencies, physicians, researchers, and consumers are expected to trust that we know how these drugs do or do not work. Importantly, we are encouraged by this understanding that any negative reactions experienced will be rare, time limited, and easily mitigated by other medical products. The possibility that there might be side effects not identified by the original research, that ‘rareness’ is relative and that ill-effects may not be time-limited or easily corrected is difficult digest. It throws a wrench in the very foundation of the heavily fortified trust in all things modern medicine.

In reality, it is very difficult to ascertain the scope and depth of potential side effects. This is due in part to the complexity of the interactions between the drug, the human, and the totality of his/her environmental exposures and stressors and in part to the economic underpinnings of these endeavors. If one had to include a broader array of variables in a drug trial, no drug would ever be approved, at least not in a timely or cost efficient manner. Instead, the initial trials utilize the most healthy of participants, perhaps excluding the disease process in question, but all other variables are excluded, both from the subject pool itself and analytically. Who wants to trial a drug on individuals typical of those who would be taking the drug; on individuals with multiple, often chronic comorbidities, for whom both chronic and acute polypharmacy are the norm and not the exception? No one. That would unfavorably skew the data. Better to have a clean subject pool and limit a priori what might be considered an adverse reaction to those that fall within the typically narrow anaphylactic framework and those that are directly related to the purported mechanisms of action of the drug itself. Addressing potential off-target effects must be eliminated or minimized; ditto for potential interactions between the drug and the unique characteristics of the individual. A clean sample and favorable data are the goal.

To that end, adverse reactions research, analyses, and reporting become a ‘see no evil’ approach. If we do not acknowledge the possibility that these reactions exist, then for all intents and purposes, they do not. This means that only the most severe and ‘on-target’ or anaphylactic reactions may be recognized. Any off-target reactions or side effects are labeled as rare and attributed extraneous variables, unrelated to the drug but entirely related some inherent weakness of the human who takes the drug.

If confronted with the prospect of negative reactions or even simply negative data e.g. the drug does not work, it is incumbent those involved to utilize analytical tools that highlight the good and hide the bad. Data or participant responses that do not fit the desired narrative must cleaned or removed, post hoc. When that does not work, it is common to select complex statistical methods that no one but the statisticians themselves understand to obfuscate negative findings. Inasmuch as few physicians and even fewer consumers understand even the most basic statistics, this all but eliminates any questions regarding the veracity of the findings. What is written in the abstract or summary is all that will matter. The lede is buried in the stats so that everyone involved might trust in the medication’s safety, trust in their own knowledge, and move comfortably along with their lives.

I admit, this is a cynical perspective, but it is hard won. After a decade of publishing HM, of researching the analytical methodologies employed by drug companies, of investigating the mechanisms of action of many popular and presumed safe drugs, it is difficult not to be jaded. So flimsy are the safety and efficacy data that one is hard-pressed not to question everything. And so here I am amidst a global pandemic for which multiple products have been rushed to market. Pressure to use these products is intense and I and others are left with the sinking feeling that we do not yet know what we think we know about these products or even what we do not know. What we do know is that the developers and manufacturers of these products have a long and well-established history of shady research practices, of burying negative data, of vilifying anyone who questions these practices, and of financing unquestioning support from politicians, ‘thought leaders’, media, and generally, anyone who might be of use. It is not difficult to recognize those same practices at play here but the desire to be safe quells those concerns for most. We’ll take anything and do anything to end this mess, except perhaps ask why we are here in the first place.

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Chandler Marrs MS, MA, PhD spent the last dozen years in women’s health research with a focus on steroid neuroendocrinology and mental health. She has published and presented several articles on her findings. As a graduate student, she founded and directed the UNLV Maternal Health Lab, mentoring dozens of students while directing clinical and Internet-based research. Post graduate, she continued at UNLV as an adjunct faculty member, teaching advanced undergraduate psychopharmacology and health psychology (stress endocrinology). Dr. Marrs received her BA in philosophy from the University of Redlands; MS in Clinical Psychology from California Lutheran University; and, MA and PhD in Experimental Psychology/ Neuroendocrinology from the University of Nevada, Las Vegas.

1 Comment

  1. Death Becomes Us should be the subtext those warnings printed on drugs.

    So, the principles of precaution (precautionary principle), and the concept of do no harm, all of that, as you might suspect, Chandler, have been tossed into the ethical dustbin of prudence and caution.

    The cure is worse than the disease. When money talks, common sense walks. A huge body of work on the unintended harms caused by cocktails of drugs pushed onto patients in Western Medicine is out there.

    Bottle of Lies: The Inside Story of the Generic Drug Boom!

    Uppers, Downers, All Arounders: Physical and Mental Effects of Psychoactive Drugs !

    The Truth About the Drug Companies — How They Deceive Us and What to Do About It!

    Enough, already!!!

    Sort of the AIDS/HIV scam — Read RFK Jr’s latest book: “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health,” which is a must-read if you want to know more about the behind-the-scenes of this giant fraud. We could talk for hours and not cover but a fraction of what’s in this book, which Kennedy calls a “devastating indictment of Tony Fauci.”

    The first cases of AIDS surfaced in 1981. Initially, the AIDS program was run by the National Cancer Institute, a separate institute inside the Health and Human Services Department (HHS). The general belief was that AIDS had a chemical etiology caused by drug use. This all changed when the HIV virus was discovered.

    Fauci started working for the NIH in 1968 as a clinical associate in the Laboratory of Clinical Investigation at National Institute for Allergy and Infectious Diseases (NIAID). He became director of the NIAID in 1984, the year after the discovery of the HIV virus, and was appointed director of the Office of AIDS Research in 1988, when that office was established. As explained by Kennedy, Fauci essentially built the NIAID around an AIDS drug called AZT.

    “AZT was a chemotherapy formulation that was so toxic it killed all the rats when they gave it to them. The inventor of AZT felt that it was unsafe for any human use, so he didn’t even patent it,” Kennedy says.

    “Very early on, the National Cancer Institute had found that when you put AZT in a culture of HIV, that killed the HIV, not surprisingly. It killed anything it touched. And so, Fauci partnered with the manufacturer of AZT … He guided that formulation through the regulatory process and tried to fast track it. He cheated terribly on the clinical trials.

    In the clinical trials, it was killing everybody. It literally kills everybody who takes it. But he was able to keep the people in the treatment group alive by giving them huge numbers of blood transfusions. It does keep them alive for the eight weeks, and based upon that eight-week trial, he got approval for AZT. It was unprecedented.

    As Kary Mullis, who won the Nobel Prize for discovering the polymerase chain-reaction (PCR) technique, said, with any chemotherapy drug, you’re supposed to give it to somebody for two weeks. Chemotherapy is designed to kill every cell in the body, but hopefully it kills tumor cells first, and you can take the person off it. The tumor dies, if you time it right, and the person doesn’t die.

    If you put somebody on that for life, like Tony Fauci was doing, every one of them is going to die. And that’s what happened. Meanwhile, there were a lot of drugs at that time that were being repurposed. Local, community-based doctors in San Francisco and New York who were treating the AIDS community were finding that these drugs treated the symptoms of AIDS, and they stopped people from dying.

    Fauci made a deliberate crusade to sabotage those, to make sure they were not available to sick people, in order to make sure that AZT would be the only solution. And AZT was the most expensive drug in history. It was $10,000 for a one-year supply [while costing just $5 per dose to manufacture, plus U.S. taxpayers paid for all of the research and development of the drug] …

    Tony Fauci basically created this template that he then used over the next 45 years, to develop toxic drug after toxic drug. He killed early treatment, and killed any protocol that competed with his pharmaceutical enterprise. A lot of people have died [as a result].”

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