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Saturday, 11.07.2020

Barry Blackwell: Corporate corruption in the psychopharmaceutical industry

Barry Blackwell’s response 2 to Charles M. Beasley’s response 2

 

           I thank Charles for his thoughtful open-minded discussion of the complex fundamental concerns this topic addresses. His calm and fair-minded views reflect the lessons learned during his long and distinguished career in the industry and how they differ from my own derived from clinical practice and academia.

           Charles presents an informative view on the topic of price and profit, particularly on how restraints on the latter appear to diminish industry interest in productivity and sustained involvement in new drug development. This is a key element in our differing points of view.

           American society clings to the belief that the cost of health care, like all commercial products, is subject to market competition. This is manifestly untrue. Based on a family’s budget citizens certainly do choose between a Cadillac or Ford, a plush suit or blue jeans, prime rib or hamburger. But when it comes to health care nobody wants to settle for death or disability and only the best care will suffice whatever the price. The uninsured and those with pre-existing conditions (most severe and persistent mental illness begins in adolescence) die prematurely, often bankrupt.

           To cite specific drug examples consider a parent’s escalating cost of an epi-pen for a child with death-dealing allergies or asthma. Or an adult with atrial fibrillation choosing a new expensive anticoagulant over generic warfarin based on persuasive colorful TV ads that tout convenience and safety along with threats of a stroke but run almost in tandem with ads of ambulance chasing attorneys soliciting victims of major bleeds.

           Of course, this is not the responsibility of just one industry but a reflection of the contemporary cultural Zeitgeist. This includes huge differentials between chief executive officer salaries and earnings of the average employee with burgeoning income disparity in a social environment of greed and addiction to money.

           Complicit in all this is a legislative and constitutional crisis; a Congress incapable of compromise staffed by politicians in thrall to bribery by lobbyists and a Supreme Court capable of Citizen’s United, the product of overt political bias.

           As Charles’ data suggests America may soon be the last nation on earth that considers health care a product for unconstricted profit rather than a basic human right constrained by government price controls. The only sane solution would be to find a political balance between the extremes of commercial and socialist ideology by defining the limits for both drug profits and healthcare benefits.

           A second serious difference in our views concerns drug development methodology and the controls or constraints imposed or neglected by a politically weak Food and Drug Administration. Most of what Charles says and suggests is sound advice but we differ in two respects: first, there is need for every early clinical controlled trial to include not only placebo but a cheap generic equivalent in the same structural category (provided there is one); secondly, given that efficacy and common side effects often become apparent in small statistically significant sample sizes, and that the possibility of rare but serious side effects or unanticipated novel alterations in clinical practice occur, a clinical effectiveness study should be completed within three years of the original Investigational New Drug application.

           Charles’ knowledge and exposition of statistical strategies in trial design are above my level of expertise but are a welcome addition to this debate.

 

April 18, 2019