{"id":167,"date":"2023-06-16T22:22:16","date_gmt":"2023-06-16T22:22:16","guid":{"rendered":"https:\/\/experimentalfrontiers.peachpuff-wolverine-566518.hostingersite.com\/?p=167"},"modified":"2023-06-16T22:22:16","modified_gmt":"2023-06-16T22:22:16","slug":"placebo-controls-gold-standard-for-efficacy-trials-have-no-place-in-safety-trials","status":"publish","type":"post","link":"https:\/\/scienceblog.com\/experimentalfrontiers\/2023\/06\/16\/placebo-controls-gold-standard-for-efficacy-trials-have-no-place-in-safety-trials\/","title":{"rendered":"Placebo controls\u2014gold standard for EFFICACY trials\u2014have no place in SAFETY trials"},"content":{"rendered":"

In a recent study of heart medications (REDUCE-IT<\/a>),\u00a0mineral oil was used as a \u201cplacebo\u201d<\/a>. Mineral oil is not a biological substance, and the body rejects it with nausea and diarrhea. Some of the\u00a0adverse effects<\/a>\u00a0of mineral oil are listed here. There is no reason to use mineral oil as a \u201cplacebo\u201d instead of (for example) olive oil except that it may make the test drug look better in comparison.<\/p>\n

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Placebos are properly used in drug trials to separate the biochemical benefit of a drug from the psychological benefit of seeing a caregiver and feeling confident that help is on the way. There is no justification for placebos in safety trials, which seek early detection of harmful side-effects that might occur in a minority of patients. The use of placebos in safety trials, particularly of vaccines, is a scam that has been augmented by a statistical sleight-of-hand, reversing the burden of proof.<\/em><\/p>\n

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The justification for placebo controls in drug trials is that mental expectation can have powerful healing effects. Drug companies should be held to a high standard \u2014 they must prove with 95% statistical confidence that it is their product that offers a benefit, not merely the relief afforded by the passage of time, or of receiving attention from a confidence-inspiring professional.<\/p>\n

When the placebo protocol was first introduced, drug manufacturers hated it. They found that, particularly for psychological medications, the placebo effect was\u00a0so powerful that their drugs were handicapped<\/a>\u00a0in the statistics, and they opined that this was unfair. The mind-over-matter effect is indeed one powerful healer. Time is another. People tend to see a professional when their pain or depression or digestion or anxiety becomes unbearable, and just because they come for treatment at a low point in their wellbeing, chances are that six weeks later they will be feeling better, no matter what. (The term for this phenomenon is\u00a0regression to the mean<\/a>.) In trials of antidepressants, typically a third of patients feel a lot better six weeks after they begin any treatment, and most drugs don\u2019t help much more than a third of depressed patients.<\/p>\n

But profit is a powerful motivator, and pharmaceutical researchers soon found ways to turn the requirement of placebos to their advantage. In testing a new drug for safety, the manufacturer must look for harmful side-effects that show up in some small percentage of people who take the drug. You can look for people who react badly to the drug just by comparing the people who have adverse symptoms to the general population \u2014 no placebo is necessary. It is helpful to have two matched populations, a test group that receives the treatment and a control group that does not; but there is no need to give the control group some other substance, because the idea of a \u201cplacebo effect\u201d does not apply.<\/p>\n

(There is such a thing as a \u201cnocebo effect\u201d, in which people who expect that they are going to be sick develop psychosomatic symptoms. It\u2019s not clear that this situation applies to drug safety trials; but even if it does, I would argue that the nocebo effect is part of the downside of giving a drug, and the safety standard should be calibrated to include psychological as well as chemical harm from a treatment.)<\/p>\n

The object of an efficacy trial is to determine how many people get better, how much better, how quickly? The body has a natural ability to recover from disease, so it\u2019s important to separate the benefits of the drug from whatever the body is doing on its own.<\/p>\n

The object of a safety trial is to determine what proportion of people suffer detrimental side effects, and to characterize those side effects. It\u2019s fair to measure responses of the test group against a control population that is untreated because there is always a background rate of people who suffer from conditions that could be erroneously attributed to the test drug. If safety is evaluated for treatment of a disease, it is fair to control for the background rate of conditions that could mimic side effects in a population that has that disease.<\/p>\n

Vaccines are a special case, because they are given to healthy people. This means that only a small proportion of recipients will (eventually) benefit from the vaccine, so a small number of people harmed becomes a significant counterweight.<\/p>\n

As control for healthy recipients, it is the background rate of headaches or sore arms or fatigue or nausea in the healthy population that should be subtracted. Childhood vaccines are a more special case because children are not able to judge long-term benefits and immediate harms, and adults must be especially conscious of protecting them. Vaccines given to infants are a very special case because their immune systems, along with the rest of their bodies, are in an intense stage of development, and anything that modifies that development is likely to have lifelong effects, for good and for ill.\u00a0 Anything that we do to a one-day-old infant may have unexpected effects \u2014 even a saline injection. Safety testing for anything that is proposed to be administered to healthy infants should pass the most rigorous long-term safety studies to assess the effects on the growing child and the future adult.<\/p>\n

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Christine Stabell-Benn<\/a>\u00a0is my teacher when it comes to long-term effects of vaccines, both beneficial and adverse. There are large effects of vaccination on the immune system in general \u2014 not just the specific disease targeted by the vaccine \u2014 and these effects can be helpful or harmful. The age and condition of the patient are important variables, and the kind of vaccine can make a difference between long-term harm and long-term health. If there is one lesson to draw from Stabell-Benn, it is that every vaccine must be individually tested for their long-term effects on exactly the population which is proposed to be receiving it.\u00a0<\/em><\/p>\n<\/div>\n

Reading through abstracts of vaccine safety reviews, I usually come across the phrase, \u201cno evidence of increased risk [ref<\/a>]\u201d or \u201cthere were no significant differences between cases and controls [ref<\/a>]\u201d. \u201cNo\u00a0significant<\/strong><\/em> difference\u201d is a term of art that means that the study in question cannot prove with 95% confidence that the vaccine is producing more side effects than the placebo. The implication here is that \u201cno news is good news\u201d \u2014 in other words, the burden of proof is on those who claim the vaccines are dangerous. Once this is stated explicitly, it becomes obvious that the logic is wrong. Safety should be exhaustively quantified and all risks taken into account before a medication is administered to newborn babies. Some might claim the same proof safety should be required of every product given to healthy adults as well.<\/p>\n

In practice, most vaccines are safety-tested not against a null control, and not against an inert (saline) placebo. In practice most vaccines are safety-tested against a different vaccine as the \u201cplacebo\u201d. Then if the new vaccine is not\u00a0provably<\/strong><\/em>\u00a0more dangerous than the old vaccine, it is considered \u201csafe\u201d. In other words, if statistics suggest with\u00a0only\u00a0<\/em>94% certainty (the opposite of p<0.05) that the new vaccine is more dangerous than the old, then the researcher can honestly report that there is \u201cno significant difference\u201d in their safety. The new vaccine is then added to the list of approved vaccines, and it is fair game to use it as a \u201cplacebo\u201d in a study of next year\u2019s vaccine.<\/p>\n

Here\u2019s what the WHO has to say on the subject:<\/p>\n

Control Vaccines: In place of a placebo, a vaccine against a disease that is not the focus of the trial is given to participants who do not receive the trial vaccine. Typically the control vaccine is a licensed vaccine for which efficacy has been demonstrated and the safety profile is well characterized. The motivation for using active rather than inert \u201cplacebos\u201d is to fulfill the ethical duty of beneficence and, sometimes, to avoid giving an injection with an inert substance. A methodological disadvantage, however, is that trials using these types of placebos provide a less perfect control. It may be difficult or impossible to assess fully the safety and reactogenicity of the trial vaccine, although its efficacy can usually be assessed satisfactorily. Such trials may also be less acceptable to regulators. Some regulators and\/or public health authorities may prefer data from a placebo-controlled trial on which to make decisions whether or not to approve or adopt a vaccine. \u2014\u00a0WHO<\/a><\/p><\/blockquote>\n

When testing a new treatment drug, it may be unethical to deprive half the patients in the study from treatment. But vaccine recipients don\u2019t have any disease, and there is no ethical imperative to recruit 30,000 additional subjects and give them a vaccine against tetanus just because you\u2019re testing a vaccine for measles on 30,000 others.<\/p>\n

Adverse events from every drug should be evaluated in comparison to what the patient would experience if he did not receive any treatment. Placebos are unnecessary, and use of toxic placebos is clearly a sham, a ruse to hide adverse events.\u00a0<\/strong><\/p>\n

In addition, the burden of proof has been reversed in these safety trials. The proper use of the 95% confidence test would be to demand 95% confidence that the drug being tested is not causing harm. But in practice, the convention is to invert the burden of proof. The new vaccine is considered \u201csafe\u201d unless there is 95% statistical certainty that it is worse than whatever vaccine was used as a \u201ccontrol\u201d.<\/p>\n

The bottom line<\/h4>\n
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What I\u2019ve described is a ratchet mechanism, by which more and more dangerous vaccines can be approved year by year, because they are being compared to the previous vaccine which is now assumed \u201csafe\u201d. Last fall, the process reached its final\u00a0reductio ad absurdum (<\/em>or maybe\u00a0reductio ad tragodia<\/em>) when the bivalent COVID vaccine was approved\u00a0without any human safety data<\/a>\u00a0being submitted to FDA.<\/p>\n

We don\u2019t know what we need to know about the safety of a great many pharmaceutical products, and vaccines given to newborn infants are in a risk class all by themselves.<\/p>\n","protected":false},"excerpt":{"rendered":"

In a recent study of heart medications (REDUCE-IT),\u00a0mineral oil was used as a \u201cplacebo\u201d. Mineral oil is not a biological substance, and the body rejects it with nausea and diarrhea. Some of the\u00a0adverse effects\u00a0of mineral oil are listed here. There is no reason to use mineral oil as a \u201cplacebo\u201d instead of (for example) olive … Read more<\/a><\/p>\n","protected":false},"author":65,"featured_media":168,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-167","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50"],"yoast_head":"\nPlacebo controls\u2014gold standard for EFFICACY trials\u2014have no place in SAFETY trials - Experimental Frontiers, with Josh Mitteldorf<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/scienceblog.com\/experimentalfrontiers\/2023\/06\/16\/placebo-controls-gold-standard-for-efficacy-trials-have-no-place-in-safety-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Placebo controls\u2014gold standard for EFFICACY trials\u2014have no place in SAFETY trials\" \/>\n<meta property=\"og:description\" content=\"In a recent study of heart medications (REDUCE-IT),\u00a0mineral oil was used as a \u201cplacebo\u201d. 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The surprising fact that our bodies are genetically programmed to age and to die offers an enormous opportunity for medical intervention. It may be that therapies to slow the progress of aging need not repair or regenerate anything, but only need to interfere with an existing program of self-destruction. Mitteldorf has taught a weekly yoga class for thirty years. He is an advocate for vigorous self care, including exercise, meditation and caloric restriction. After earning a PhD in astrophysicist, Mitteldorf moved to evolutionary biology as a primary field in 1996. He has taught at Harvard, Berkeley, Bryn Mawr, LaSalle and Temple University. He is presently affiliated with MIT as a visiting scholar. In private life, Mitteldorf is an advocate for election integrity as well as public health. He is an avid amateur musician, playing piano in chamber groups, French horn in community orchestras. His two daughters are among the first children adopted from China in the mid-1980s. Much to the surprise of evolutionary biologists, genetic experiments indicate that aging has been selected as an adaptation for its own sake. This poses a conundrum: the impact of aging on individual fitness is wholly negative, so aging must be regarded as a kind of evolutionary altruism. Unlike other forms of evolutionary altruism, aging offers benefits to the community that are weak, and not well focussed on near kin of the altruist. This makes the mechanism challenging to understand and to model. more at http:\\\/\\\/mathforum.org\\\/~josh\",\"sameAs\":[\"http:\\\/\\\/AgingAdvice.org\"],\"url\":\"https:\\\/\\\/scienceblog.com\\\/experimentalfrontiers\\\/author\\\/joshmitteldorf\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Placebo controls\u2014gold standard for EFFICACY trials\u2014have no place in SAFETY trials - Experimental Frontiers, with Josh Mitteldorf","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/scienceblog.com\/experimentalfrontiers\/2023\/06\/16\/placebo-controls-gold-standard-for-efficacy-trials-have-no-place-in-safety-trials\/","og_locale":"en_US","og_type":"article","og_title":"Placebo controls\u2014gold standard for EFFICACY trials\u2014have no place in SAFETY trials","og_description":"In a recent study of heart medications (REDUCE-IT),\u00a0mineral oil was used as a \u201cplacebo\u201d. Mineral oil is not a biological substance, and the body rejects it with nausea and diarrhea. Some of the\u00a0adverse effects\u00a0of mineral oil are listed here. There is no reason to use mineral oil as a \u201cplacebo\u201d instead of (for example) olive ... 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The surprising fact that our bodies are genetically programmed to age and to die offers an enormous opportunity for medical intervention. It may be that therapies to slow the progress of aging need not repair or regenerate anything, but only need to interfere with an existing program of self-destruction. Mitteldorf has taught a weekly yoga class for thirty years. He is an advocate for vigorous self care, including exercise, meditation and caloric restriction. After earning a PhD in astrophysicist, Mitteldorf moved to evolutionary biology as a primary field in 1996. He has taught at Harvard, Berkeley, Bryn Mawr, LaSalle and Temple University. He is presently affiliated with MIT as a visiting scholar. In private life, Mitteldorf is an advocate for election integrity as well as public health. He is an avid amateur musician, playing piano in chamber groups, French horn in community orchestras. His two daughters are among the first children adopted from China in the mid-1980s. Much to the surprise of evolutionary biologists, genetic experiments indicate that aging has been selected as an adaptation for its own sake. This poses a conundrum: the impact of aging on individual fitness is wholly negative, so aging must be regarded as a kind of evolutionary altruism. Unlike other forms of evolutionary altruism, aging offers benefits to the community that are weak, and not well focussed on near kin of the altruist. This makes the mechanism challenging to understand and to model. more at http:\/\/mathforum.org\/~josh","sameAs":["http:\/\/AgingAdvice.org"],"url":"https:\/\/scienceblog.com\/experimentalfrontiers\/author\/joshmitteldorf\/"}]}},"jetpack_featured_media_url":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-content\/uploads\/sites\/7\/2023\/06\/placebo.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/posts\/167","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/users\/65"}],"replies":[{"embeddable":true,"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/comments?post=167"}],"version-history":[{"count":0,"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/posts\/167\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/media\/168"}],"wp:attachment":[{"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/media?parent=167"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/categories?post=167"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/scienceblog.com\/experimentalfrontiers\/wp-json\/wp\/v2\/tags?post=167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}