Double Blind or Just Blind

In many cases, just the chance of getting access to a promising drug to save one’s life is the bait used to enroll patients in a double blind randomized controlled trial (RCT). Regulators wrongly justify the RCT as the only scientific means to “protect the public” and prove efficacy before approving any drug.  To the patient, it is a blind chance.  Flip a coin, heads you win a chance to live, tails you die.

A controlled trial is a comparison between two groups –or study arms: the drug arm and the control arm. When the  control arm is a placebo (“sugar pill”), many medical professionals and advocates consider it downright murder.  Even when the control arm is an approved drug, when patients who are not responding can’t change to something else that might work, many still consider that type of trial equivalent to murder.  Others consider RCTs a necessary human sacrifice in the pursuit of data for “public safety.”  It is rather amazing that with the efforts of animal activists to protect animals, activists haven’t already risen up to protect human beings including children from this practice that in deadly diseases has a very different implication than in other conditions such as incontinence.  RCT’s are not the only way to assess drugs, and in deadly diseases, usually cause far more harm than good, both for the patients in the trials and for the general public with delayed or denied drug approvals based on fundamentally flawed measures.

Today, there are over 900 cancer drugs in the pipeline.  Assuming the current RCT system, the FDA would in essence be sanctioning 900,000 patients treating their disease with sugar pills, thereby ensuring the known death rate from the disease.  And for the other 900,000 in the drug groups, ensuring they are not provided the total treatment they need to actually beat cancer (since they can’t add or change to other therapies), thereby ensuring little additional survival for anyone except for the few responders in any given trial.

If RCT’s are going to continually be used to measure the wrong things, all we will successfully do is sacrifice many human beings for erroneous data and ensure the loss of the many tools that doctors actually need to defeat cancer and other diseases.

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