The Dupilumab studies as reported in the New England Journal of Medicine and the Journal of the American Academy of Dermatology and by me on discussed in my four prior posts exhibit multiple violations in the study of new drugs and scientific reporting.
- Inclusion of patients: from my experience with 4000 totally similar patients none of those admitted into the study were ‘bad eczema’ patients, they were all corticosteroid addicted atopic dermatitis patients. The wrongly named patients were being studied. In my 4000 patient experience there is no such thing as ‘bad, prolonged, chronic eczema.’ The on-going skin problem was all driven by steroids.
- Multiple centers with multiple researchers were involved in the study. In the NEJM article 25 investigators are listed. They were allowed under their personal discretion to give steroids to flaring patients. Twenty- five subjective researchers were upsetting a supposed objective study? The protocol was set up this way because the researchers could not enroll ‘clean’ atopic dermatitis patients. To repeat the steroids were the driving force in the ongoing skin problem.
- The criteria to ascertain differences between drug and placebo were all subjective in both journal articles: namely sleeplessness, itching (pruritus), anxiety and personal comments of well-being. Studies with sleeping pills, antihistamines or antidepressants could have studied and would have probably given similar results. There is no need for a monoclonal antibody study.
- There are no comments concerning the dermatitis and skin condition. There are no photos. Did any patient show evidence of ‘bad eczema’ clearing?
- There are no objective assessments by any evaluators, only patient reporting of symptoms. This approach of subjective responses has been demeaned in many studies, especially in homeopathy, herbal studies, food supplements etc. Is this drug at that low level of science studies?
- There are multiple treatment schedules. Therefore, there were multiple studies rolled into one which makes it very difficult to assess results.
- In the past two days the national newspapers have published negative comments about the $37,000 yearly price for this drug. Not only would the price be a travesty if the drug even worked semi-miracles, but it is outrageous fraud perpetrated on all of us since the money spent will yield little because the drug does not deliver at all.