Urfalino (Philippe)

After the Withdrawal of Vioxx©
The state of tension in the pharmaceutical sector
since the withdrawal of Vioxx©, and the crisis of medicine agency authority

Philippe Urfalino

Medicines are industrially produced, marketed health care goods whose design and production require a great deal of scientific medical knowledge, as does the work of defining how to use them correctly. Though medicines have become much more effective than they once were, they have also become more dangerous. When Western states became aware of this danger in the 1960s, they assumed the right to control market entry of new medicinal products. A remedy’s status can only switch from molecule to full-fledged medicinal drug if that remedy obtains a Drug Approval. Approval is based on evaluation (through clinical trials) of the proposed medicine’s beneficial effects on a specific pathology, as weighed against the possible risks involved in consuming it: harmful, possibly fatal side effects.

The United States Food and Drug Administration (FDA) has been in existence for over a century, but it was not until the 1990s that public health agencies were created in Europe, first in the different countries, then for the European Union as a whole (the European agency was created in 1995). The purpose of these agencies was to improve on previous administrations’ evaluation of medicinal drugs before and after marketing.

Since around 2000, and particularly after the worldwide withdrawal of two blockbuster drugs in 2001 and 2004, the agencies, particularly the FDA, have come under strong criticism from the major medical journals, the media, the parliaments that set up committees and hearings on the problem, and the various public groups that survey them/various watchdog groups.

My presentation aims to account for what is too vaguely termed a crisis of confidence in Western drug evaluation agencies, and by examining this situation, to determine what conditions these agencies’ authority and credibility.

The agencies’ role is to authorize or refuse to authorize the marketing of proposed remedies, to monitor their effects as knowledge of those effects evolves, and to restrict their use or even take them off the market altogether if they deem it necessary. To fulfill these functions, the agencies have to make “reasoned use of available scientific data” in making decisions and transmitting what they consider useful information to prescribers and patients. These decisions and actions must all be founded on reason; that is, they must be supported by arguments and made in the service of public health, a certain idea of the collective good. But in performing this function, agencies makes use of studies conceived by the firms and experts that are very likely to be closely connected to pharmaceutical companies. Thes companies stand to be considerably affected financially and commercially by agency statements about a molecule’s therapeutic effectiveness and safety and by variations in medicine evaluation.

In sum, the agencies are charged with making decisions and validating statements about therapeutic effectiveness impartially—that is, in the service of public health rather than firms’ interests—on the basis of knowledge and competence whose conditions for production and use are strongly linked to the self-interested initiatives of the drug companies.

Given that the authority of these agencies is first and foremost epistemic—that is, it depends on the truth value attributed to therapeutic effectiveness statements—the first problem for the agencies is to ensure that in their activities they are free of any and all ties to the interests of the drug companies. But they also have to inspire confidence in public opinion leaders and the public at large, in a situation of continuous controversy and debate and repeated suggestions or accusations that their therapeutic effectiveness statements are partial (the experts are working for the firm; the agencies have been captured).

My talk will discuss the following points:

What dashed expectations led to the worldwide market withdrawal of two medicines: cerivastatine and Vioxx®?
What stable factors explain the recurrence of controversy about the validity of medicine effectiveness statements and agency decisions?
Why do these controversies have such a destabilizing effect on the agencies?
What measures could agencies and companies take to improve a situation that hurts both of them?

Bibliography

Thomas Bodenheimer, “Uneasy Alliance. Clinicla Investigators and the Pharmaceutical Industry”, New England Journal of Medicine, 18 May, 2000.

goldman_experts.pdf — A. Goldman, “Experts: Which Ones Should You Trust?,” Philosophy and Phenomenological Research, Vol. 63, No. 1, July 2001, pp. 85-110.

Harry Marks, “Making risk visible: the science and politics of adverse drug reactions”, Max Plank Institut für Wissenschaftsgeschichte, Berlin, November 2006.

Edwards Ralph, “What Are the Real Lessons from Vioxx® ?”, Drug Safety, 2005, 28 (8), p. 651-658.

Mark Warren, “Democratic theory and trust”, in Warren (ed.), 1999, Democracy and Trust, Cambridge University Press.