After having cured 4000 plus patients with steroid addiction and Red Skin Syndrome, I feel duty bound to offer sound advice to those still mismanaged suffering patients still floundering in their care. In that regard I look at every new drug offering promise of improvement or cure to these patients. I dissect the quality of the study and tear apart interpretations of the results. Too many times in the past the force of profits from the drug companies and the force of notoriety from the researchers make strange bedfellows and poor protocols and reportage to practicing physicians.
The drug Dupilumab for which a long blog was written and posted a few days ago necessitates deeper criticism and comment. The drug studies have been published in two august medical journals, namely the Journal of the American Academy of Dermatology (JAAD) and the New England Journal of Medicine (NEJM). Coincidentally the sponsoring drug companies, Regeneron and Sanofi previously in June of 2016 sent out a ‘release to physicians’ that Dupilumab used with topical corticosteroids was superior to treatment with topical steroids alone in long term Phase Three trials. The patients discussed in the release were ‘inadequately controlled moderate to severe atopic dermatitis patients.’ Coincidentally marketing had already begun by the National Eczema Association (NEA) touting the ‘breakthrough of this new drug’, even before FDA approval.
Drug study researchers and journal articles are invariably believed by the practicing reading physicians. Therefore there must be a huge ethical restraint on the reportage. Practicing physicians rarely read whole article of most studies, probably because of time restraints. They believe the researchers, the writers, the journals (peer reviewing) and the conclusions. They rarely view the graphs or read the charts. They believe what they are told since the journals are ‘sacrosanct’ in their wisdom. But all negatives must be addressed in the conclusions, not to lead doctors and patients astray. Profits and marketing hype have no place in these journals.
I find several aspects of the studies and the comments to be scientifically deplorable. I will therefore in the next several blogs offer my critique and hopefully dispel any false hope promulgated by the drug companies, the research physicians and NEA, that this is a major breakthrough drug.