The Pharmaceutical Industry

The Pharmaceutical IndustryA Dysfunctional Relationship

We try never to forget that medicine is for the people. It is not for the profits. The profits follow.

George Merck, 1950

A dysfunctional Relationship239 US settlement payments amounting to $30.2b have been paid

COI- 84% of doctors having a relationship with pharmaceuticals.

RoadmapProfit-fixationInstitutional Corruptionthe Physician Payments Sunshine Act (PPSA)

Profit FixationCostly R&DNew molecular entities (NMEs) 3 clinical trial phasesOnly 1 out of 20 NMEs an average of 12 years$5.3 billion

Compulsory LicensingResort to compulsory licensingAccessible to the public.

Bayer Corporation v Natco Pharma Limited

1995 to 2011 - there were 24 cases of compulsory licensing for drugs

Institutional corruptionImproper dependencies

Trial methodsFDA depends on scientific data from pharmaceuticals

Skew results to exaggerate the efficacy. Or downplay side-effects.

PharmacovigilancePost trial for adverse side effects.Able to choose trial designsDelay comparative studies Vioxx Gastrointestinal Outcomes Research (VIGOR) & Weinblatt.

Source of InformationPharmaceutical physician relationshipContinual Medical Education (CME)TalksMedical journalsFunding to sustain operations

Physician patient relationshipsInformation asymmetry more pronouncedNo discretion Fiduciary duty erodeExploit the unequal relationship

Govt regulationDisproportionate influence over the entire process.Free market non-existentInformation asymmetriesOverdependencies

High Sunken costs- first mover disadvantage

"We don't want to do anything that puts us at a competitive disadvantage. Novartis CEO

Physician Payments Sunshine Act Sunshine ismthe best disinfectant?

ppsaPayments or transfers of value of more than $10.

Knowingly failing to report- fine up to $1m.

Aug to Dec 2013.4.4 b transactions- $3.5bInaccuracies & 1.7m transactions de-identified.

ppsaDisclosure is of limited useOnus placed on patients with limited means- Need of medical knowledge-Second opinion?

II. Doesnt minimize institutional corruption and the disproportionate influence.

reformsFDA to conduct pharmacovigilancePost trialsSeparate funding for CME talksTalks to be funded by taxExpanding the PPSA to ban giftsAid vulnerable patients

Sunshine is NOT the best DisinfectantThe end