Dr. David Healy-April 23, 2013
“Instead the effectiveness criterion has made medical conditions into a target for treatment and in so doing it set these conditions up for capture by pharmaceutical companies and their marketing departments. The effectiveness criterion created the inevitability of what is now called disease mongering.
To have to fish for possible effectiveness in some heterogeneous clinical condition is not what controlled trials were designed for. Controlled trials discover nothing. Even worse, the effectiveness claims for many drugs rest on minor surrogate marker or rating scale changes in trials that are powered to ensure that clinically insignificant changes achieve statistical significance. It would be entirely possible to prove Snake Oil was effective on this basis.”
“Meanwhile in the real world, there are in fact more dead bodies in the active treatment arms of most blockbuster studies than in the placebo arms. The claim that these surrogate or rating scale changes demonstrate effectiveness therefore as a matter of logic does not stack up.
Aside from dead bodies,we know that many of those who “benefit” will have enduring problems from physical dependence and other legacy effects from treatment. This is not effectiveness as the 1962 regulations envisaged. We have ended up instead in a world in which hints of an effect are used to gain market entry for drugs and when we use these drugs mindlessly on the basis that they are effective, if the RCT evidence is to be believed, we produce greater disability in the long run than if we never had them. The effects may turn out to be worse than if we had encouraged chronic alcohol intake.”
“Little noticed is the fact that the RCT processor malfunctions badly in a number of ways.
Whenever a drug and an illness produce superficially similar effects from pain, to nausea, to suicide, it is possible to hide drug-induced problems. Antidepressant trials can be “gamed” so that drugs known to cause suicide will show up as preventing suicide rather than causing it. Perverse outcomes like this are built into RCTs (See The Best Bias that Money can buy, Heads we win, tails you lose).”
“In fact where the placebo had once seemed a form of hypnosis, the focus on effectiveness and specificity has turned RCTs into a form of hypnosis. Doctors are now in thrall to the spell of the hypnotist from Oz, who’s RCTs can even make Snake Oil to be effective.
Hypnotized by the Piper’s tune, doctors and patients are lured to consume 6, 8 or 10 drugs at the same time – what could be wrong with taking drugs that work. Infants, elders are lined up and medicated. The only ones who may be saved are those who have been previously crippled or injured on whom the music has ceased to work. Few can see what is going on around them or the name of the theatre in which they are being duped – The Empire of Humbug.”
trackback to Public Citizen:
“Seeking Additional Patient Bases
In addition to plumbing their own files for potential experimental subjects, some researchers pay “finder’s fees” to other doctors who do not even conduct the research: “Occasionally, investigators offer fees to encourage referrals from other physicians or nurses,” such as an offer of $75 to physicians or nurses for each subject referred, according to the Report. The use of patients reached through patient advocacy groups, also described in the Report, similarly has the taint of using a relationship of trust to recruit patients who might otherwise not be interested in participation in such experiments.”
*So now, with the neurotechnology how could we resonably expect that to work with a backdrop like this?