Editor`s Opinion: Has the Pendulum Reached the Sun?

   In a recent issue of Ostomy Wound Management, Morris Magnan and JoAnn Maklebust observed, “Policy has an interesting way of shaping both science and practice.”¹ They expressed the hope that recent Centers for Medicare and Medicaid Services (CMS) reimbursement changes for acute care facilities might provide the impetus to develop a theory of pressure ulcer prevention.

   The new CMS endeavor is rather unique in its timing — in most areas, the policy regulation pendulum has been moving toward deregulation. Policies that guide the regulation process shape our world. Recently, the magnitude of negative effects from certain policies has increased substantially. World markets are feeling the reverberations of changes in US economics from food (corn) subsidy to safety warnings and product recalls (children’s toys, pet food, infant formula, balloon catheters, and automatic external defibrillators) to manufacturing deficiencies (affecting more than 30 different generic drug products).² Roughly two thirds of factories outside the US that export medications to our citizens are not visited by the FDA³ — not surprising considering, as the editors of the British Medical Journal observed 3 years ago, “Drug safety is a political graveyard — political pressures exist to restrain public expenditure and reduce regulation in healthcare generally.”⁴ As if to prove that point, 1 day following the FDA announcement that one company’s drugs may cause serious side-effects, its executives issued a statement assuring there are no problems, they are working with the FDA, and have retained Rudy Guiliani to “…lead a team for resolving the issues with FDA.”⁵

   University of Pennsylvania law professor David Skeel notes that regulations are absolutely necessary to curb corporate malfeasance.⁶ In his book Icarus in the Boardroom, Skeel calls executive and CEO efforts to side-step oversight and take excessive risks the “Icarus effect,” a nod to the Greek Icarus who, exhilarated by the thrill of being airborne, ignored warnings from Daedalus about flying too close to the sun and died when his wings melted. Skeel argues that regulations are needed to protect CEOs against their inherent tendencies to take too many risks.

   In my mind, the problem is the distance between policy makers/boardroom executives and the people affected by their decisions. The decision-makers may lose some money but won’t be homeless as a result of their actions. They don’t have to assuage the pain of a pressure ulcer that could have been prevented. They don’t have to hold the child who is dying after drinking tainted formula or watch a woman writhe in pain after taking an antibiotic or nurse their mother who had a stroke because the “anti” hypertensive medication increased her blood pressure. At the very least, regulation should reinforce accountability.

   Professor Skeel observes that serious corporate debacles usually provoke outrage and galvanize public opinion in favor of corporate reform. Let’s hope he is correct. The recent rash of legislative and resultant corporate failures to protect the financial stability of the world and the safety of its people would suggest that the pendulum of deregulation has reached the sun.

1. Magnan, M, Maklebust J. Advancing the science of pressure ulcer prevention. Ostomy Wound Manage. 2008:54(9):6.

2. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd. and an import alert for drugs from two Ranbaxy plants in India. September 16, 2008. Available at: www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html. Accessed September 17, 2008.

3. Bruderlin-Nelson C. FDA halts Ranbaxy India Imports. Available at: www.fiercepharma.com/ story/fda-halts-ranbaxy-india-imports/2008-09-17. Accessed September 17, 2008.

4. Waller PC, Evans SJ, Beard K. Drug safety and regulation (Editorial). BMJ. 2005;331(7507):4–5.

5. Ranbaxy Laboratories Ltd. retains former New York City mayor Rudy Guiliani to lead team in resolution of issues raised by US Food and Drug Administration. Gurgaon, India. Sept.18, 2008. Available at: www.fiercebiotech.com/press-releases/ranbaxy-laboratories-ltd-retains-former-new-york-city-mayor-rudy-giuliani-lead-team-0. Accessed September 19, 2008.

6. Skeel D. Icarus in the Boardroom: The Fundamental Flaws in Corporate America and Where They Came From. Law and Current Affairs Masters. New York, NY: Oxford University Press; 2005.