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Chapter 5 Drug Promotion, Clinical Trials, and Conflicts of Interest

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Chapter 5 Drug Promotion, Clinical Trials, and Conflicts of Interest Chapter 5 Drug Promotion, Clinical Trials, and Conflicts of Interest "Gifts buy you time with a doc, time that might change his mind. .Money is the big resource. The pads and pens are great for access, but the dinners and what costs money. CDs, handheld computers, everything given in the name of research this is what's thrown at docs to get them to change their minds." A Former Detailer Drug industry lobbies do not appreciate people who squeal, the outstanding instance is the documented case by Stanley Adams in his book Roche Versus Adams.1 Stanley Adams was an executive who did what he felt was right by alerting the European Commission to cartelisation and anti-competitive practices by Swiss-based pharmaceutical giant Hoffmann-La Roche. The Commission fined Hoffmann for abuse of its dominant position in the bulk vitamin market but during antitrust proceedings disclosed information that enabled Hoffmann to identify Adams, who was consequently arrested and convicted for unauthorised disclosure under Swiss law. Adams was hounded by Swiss law, arrested while crossing the borders, and thereafter things went horribly wrong for him and his family including the 'suicide' of his wife. Adams successfully sought damages from the Commission, which was held by the European Court to have failed its obligation "not to disclose information of the kind covered by the obligation of professional secrecy, in particular information about undertakings, their business relations or their cost components." In 1999, Roche was fined US $500 million in the US for a repeat of its offence. A more recent instance is that of cardiologist Dr. Eric Topol. Within a week of his testifying against Merck he was deprived of his position as chief academic officer at Cleveland Clinic's Medical College.2 His demotion immediately after he lambasted Merck in a videotaped testimony, in the third Vioxx (rofecoxib) lawsuit to reach trial, was too much of a coincidence. Dr. Topol had questioned Vioxx's safety for years and said in his testimony, played in court, that he believed that Merck acted irresponsibly and committed scientific misconduct when it promoted Vioxx. For those who want to play ball, the game starts with forms of entanglement right from the intern stage, later blossoming into cozy connections. We discuss these in this chapter and how it affects patients. 1. "Forms of Entanglement" World over, and in India specifically, medicines are promoted by all means fair and foul. It is understandable, to some extent, that pharma companies aggressively market their drugs; and persuade doctors by a variety of means. But it is not clear why doctors should pretend that such marketing does not influence their prescribing behaviour and therefore it is okay not to resist the marketing overtures of drug companies. Drug promotion is carried out by means of heavy advertising, frequent visits to private medical practitioners by the medical representatives of pharmaceutical companies with literature on their drugs, 208 AL ayP erson'sG uide free sample of drugs, and even blatant bribes like diaries, posters, calendars, pens, or other gifts, and sometimes also invitations to medical conferences held in five-star hotels with lavish meals and expensive give-aways. Drug companies also encourage articles in newspapers and magazines, television and radio programmes, release promotional materials as news stories about latest developments in medical field and sponsor television programmes. Thus, drug promotion is a comprehensive attempt to influence health workers and the general public to suspend their critical judgment.3 (See box on Forms of Entanglement and also box on Opinions of International Panel on Drugs Advertised in Indian edition of BMJ.) Forms of Entanglement:Who pays for the Pizza?4 lFace to face visits from drug company representatives lAcceptance of direct gifts of equipment, travel, or accommodation lAcceptance of indirect gifts, through sponsorship of software or travel lAttendance at sponsored dinners and social or recreational events lAttendance at sponsored educational events, continuing medical education, workshops, or seminars lAttendance at sponsored scientific conferences lOwnership of stock or equity holdings lConducting sponsored research lCompany funding for medical schools, academic chairs, or lecture halls lMembership of sponsored professional societies and associations lAdvising a sponsored disease foundation or patients' group lInvolvement with or use of sponsored clinical guidelines lUndertaking paid consultancy work for companies l Membership of company advisoryboards of "thought leaders" or "speakers' PLoSM ed bureaux" lAuthoring "ghostwritten" scientific articles lMedical journals' reliance on drug company advertising, company purchased reprints, and sponsored supplements A senior professor of medicine of the prestigious Government of India post-graduate institute, JIPMER, Pondicherry, in a response to a BMJ editorial,5 "Marketing of Medicines in India: Informing, influencing or inducing?," wrote: "In India and several other countries, the marketing ploys include an upgraded 5-C technique: 1. Convince by facts and figures 2. Confuse by misrepresenting data or using junk data 3. Coax by appealing to pragmatism: "All said and done Doctor, your patients expect you to prescribe..." 4. Corrupt and (if that fails - it does with upright Doctors even today) 5. Cry (usually a sob story of the plight of being a sales executive with a target to meet or else...). Several of my friends experience the 5-C ploy all the time. Infact we have made a video role-play to sensitise our undergraduate medical students on how to face up to the 5-C challenge.” DrugP romotion,C linicalT rials 209 Opinions of International Panel on Drugs Advertised in Indian Edition of BMJ 6 lTrental 400 (pentoxifylline): "The advertisement makes unsubstantiated claims of improvement in mental function." (This drug is marketed only for peripheral vascular disease in America and Britain; in India it is indicated for cerebrovascular disease as well.) lRelaxyl (diclofenac): "The claim 'gentle on the gastrointestinal tract' is not in accord with the reported high incidence of gastrointestinal side effects (up to 30% in Australian approved product information)." lAlarsin products (Indian preparation): “There is no information on active constituents, side-effects, or contraindications, and the claims made are unsubstantiated.” lKeflor (kefaclor): "Makes unsubstantiated claims such as 'respiratory specific.''' lFludac (fluoxetine): "This advertisement distorts the side-effect profile by mentioning only the advantages it has over tricyclic antidepressants. There is no information on contraindications or dosage." lGlobac (haemoglobin ferric ammonium citrate, copper sulphate, manganese sulphate, zinc sulphate): "No evidence for therapeutic effect is given, and there are no clear indications for use." lMentat (Indian preparation): "There is no information on constituents, indications, precautions, or dosage. There is no evidence given for clinical efficacy, and the reference is to a study in an obscure (in house) journal." lCiprodac (ciprofloxacin): "The claim 'super power in your hands' is meaningless. There is no mention of the generic name, constituents, contraindications, or side-effects." lCiprowin (ciprofloxacin): "Makes unsubstantiated superlative claims such as 'surgical infections: most effective and cost effective therapy' and ‘LRTI: better than third generation cephalosporins.''' lCiprobid (ciprofloxacin): "The claim 'superior to chloramphenicol, aminoglycosides, cephalosporins in ... bronchopneumonia, osteomyelitis' is misleading." (Just to give an idea of the detail a drug company goes to influence a doctor, in the following three pages, Exhibits 1-2, we give Merck's instructions to its sales force on how to obfuscate when the Vioxx debacle was just rolling in. For other related documents see <http://reform.house.gov/GovReform/Hearings/> on Vioxx.) David Werner 210 AL ayP erson'sG uide Exhibit 1 DrugP romotion,C linicalT rials 211 Exhibit 1 (contd.) 212 AL ayP erson'sG uide Exhibit 2 DrugP romotion,C linicalT rials 213 A more recent Time magazine7 article reporting on the No-Free Lunch campaign8 launched in the US had this to say:9 "For decades, taking gifts from drug makers has been business as usual for doctors. The pharmaceutical industry spent $22 billion on marketing to physicians (including free samples) in 2003, up from $12.1 billion in 1999, according to data from Pharmaceutical Research and Manufacturers of America (PhRMA). The industry is on track to spend almost $3 billion in 2005 solely on meetings and events for physicians, according to Verispan, a health-care market-research firm in Pennsylvania. The drug industry argues, with reason, that gift giving evolved as a necessary tool for sharing information about new drugs with busy physicians who needed incentives to stop and listen." According to Dr Gulhati, Editor of MIMS India, companies routinely spend on "educational" seminars: "lavish but misleading events based on selective quotes from selected articles and inevitably such events are followed by lavish meals laced with alcohol… Some years back German Remedies held such so-called educational seminars all over India where the virtues of anti-hypertensive clonidine were explained in great detail. Within a month, another division of the same company held another seminar where another anti- hypertensive Xipamid was placed at the top while clonidine was at Number 10 the bottom!"10
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