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Doctors and drug companies
Blumenthal
N Engl J Med
2004 |
- When a great profession and capitalism interact, drama is likely to result
- Surge in spending on prescription drugs and publicity surrounding prominent legal cases related to marketing has focused attention on relationships
- Marketing expenditures estimated from $12—15 billion yearly (£8—15k/physician)
- Relationships have potential consequences for society
- Most physicians have a positive attitude towards their interactions with companies
- Pronouncements embrace the view that relationships are ethically appropriate, often beneficial and certainly unavoidable
- Doctors and leaders of companies are mature, consenting parties in relationships that both are highly-motivated to maintain
- Politically impractical for governments to adopt the kind of draconian ban on relationships that their strongest critics favour
- Will be ongoing cycles of scandal and reform for the foreseeable future
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The company we keep: why physicians should refuse to see pharmaceutical representatives
Brody
Ann Fam Med
2005 |
- Interactions present a challenge to both professional integrity and time management
- Empirical data suggest interactions increase the chance that the physician will act contrary to duties owed to the patient
- Clinical competence includes accepting well-grounded medical evidence as the correct basis for one's actions
- Ideally a physician should interact but do the research necessary to counterbalance bias in communication messages
- Obligation to see reps for samples is not compelling
- Reps are honest business people, mostly, who have no power over professional integrity
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A national survey of physician-industry relationships
Campbell et al
NEJM 2007 |
- 3167 physicians in 6 specialties: response rate of 52% (n=1684)
- 94% some relationship with industry
- 83% food in workplace
- 78% samples
- 35% reimbursement for costs to attend CME/professional mtgs
- 28% payments for consulting/lectures/trial enrolment
- Cardiologists twice as likely as FPs to receive payments
- FPs met reps most frequently (16/month vs anesth 2/month)
- Variation by speciality, practice type, activities
- Industry focuses marketing efforts on physicians perceived to influence prescribing behaviours
- High prevalence of relationships underscores need to consider implications carefully
- Guidelines need to be developed specific to context of speciality and setting
- Study did not assess risks, benefits, appropriateness of relationships
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Doctors and drug companies – scrutinizing influential relationships
Campbell
NEJM
2007 |
- Nature, extent and consequences of relationships have become one of the most fiercely-debated issues in health care today
- Interactions are ubiquitous
- If relationships didn't affect behaviours companies wouldn't spend $19 billion each year establishing and maintaining them
- Many, if not all, of the drugs currently on the market simply wouldn't exist if it weren't for relationships
- Financial rewards from industry may reinforce a culture of entitlement
- Physicians vehemently deny their relationships have negative effect
- Costs of incentives are passed to patients in form of higher drug prices
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Institutional academic-industry relationships
Campbell
JAMA
2008 |
- IAIRs exist when there is a financial relationship/interests in public/private company
- 459 Academic Chairs surveyed – 60% have relationships with industry
- 27% consultant
- 27% member of scientific advisory board
- 14% paid speaker
- 67% all departments had relationships
- Clinical departments more likely to receive research equipment
- 65% receive funds for CME
- 37% funds for residency and fellowship training
- 52% believed positive effect on ability to provide educational offerings
- Relationships highly prevalent and need active disclosure and management
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Interactions of the public and private sectors in drug development: boundaries to protect scientific values while preserving innovation
Cassell
Cleveland Clinic Journal of Medicine
2007 |
- Industry, academia and government 'triple helix' have interwoven relationships in research
- Development is best conducted in a collaborative environment
- Development sustained by publicly and privately funded research
- Industry motivators to drive innovation:
- Market-based pricing
- IP protection
- Predictable, expeditious regulatory climate
- Sustained public support for basic research
- Public policy protecting complementary, synergistic roles of research – least understood
- Traditionally academia/government scientists performed basic research while industry involved in applied and translational research
- Roles blurred through biotech industry and Bayh-Doyle act to facilitate technology transfer from public to private sector
- Potential conflicts arise because:
- Number and diversity of stakeholders
- Enormous financial stakes
- Poor understanding of nature of research
- Highly interwoven:
- 1 in 3 public biotech firms in US 35 miles from UC campus
- 1 in 3 CA biotechs founded by UC scientists (includes Amgen, Genentech, Chiron)
- UCA founded 113 biotech companies in San Diego area
- Share of funding for clinical research in UC system from industry x10 than share from NIH
- Public understanding (Research! America, 2004):
- 41% know most development conducted by pharma
- 25% thought institutions and companies work collaboratively
- 91% thought institutions should work together
- 88% believed it a good idea for companies to fund research in universities, hospitals and institutions
- 69% believed scientists should be able to profit from their discoveries
- Pharma one of most heavily-regulated industries
- Government oversight: US FDA and OIG and Department of Justice
- Industry trade associations
- Professional society memberships
- Individual companies
- Three commonsense notions:
- High level of clarity in COI rules
- Accountability must be relentless
- Promote transparency
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Physicians and drug representatives: exploring the dynamics of the relationship
Chimonas et al
JGIM
2007 |
- Medicine is a $2-trillion industry
- Conflicts arise when interests or commitments compromise independent judgment or loyalty to patients
- Used focus groups to explore physicians beliefs about interactions and techniques for managing conflicts between marketing and patient care
- Physicians use cognitive dissonance to psychologically manage their recognition that encounters with detailers are intended to influence prescribing and potentially undermine their moral integrity as altruistic practitioners
- Elimination – no-one practiced
- Rationalization – frequently used and contradictory
- Denial – not responsible for COI
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Pharma goes to the laundry: PR and the business of medical education
Elliott
Hastings Center Report
2004 |
- MECCs are money launderers for the pharmaceutical industry
- The magnitude of the phenomenon had become evident through litigation
- 11% articles in 6 major American publications are ghostwritten
- EG Zoloft publications by Current Medical Directions
- 55 articles by CMD vs 41 traditionally authored
- Ghostwritten in more prestigious journals
- Citation rate >5x ghostwritten
- Paint better profile of drug than traditionally-authored
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Should the drug industry work with key opinion leaders? NO
Fava
BMJ
2008 |
- Proliferating connections between doctors and industry have bought credibilityof clinical medicine to an unprecedented crisis
- Corporate actions have placed profit over public health
- Companies aim to get universal prescribing by manipulating evidence and withholding data
- Industry tactics include 'experimercials', 'infomercials' and CME
- OL are hired to perform and get money, visibility and power
- Patients and society are harmed by these practices as a result of irrational prescribing, omission of safety issues and increased costs
- When trust goes, so to does the healing power of the doctor
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Following the script: how drug reps make friends and influence doctors
Fugh-Berman and Ahari
PLOS
2007 |
- In 2000 more than $4.8 billion was spent on detailing by sales reps
- Reps increase drug sales by influencing physicians using finely titrated doses of friendship
- Reps are trained to asses personalities, practices and preferences
- Personal info may be more important than prescribing preferences
- Best reps tailor messages constantly according to their client's reaction/category
- Friendly/outgoing = cultivate and frame everything as friendship
- Aloof/skeptical = armed with articles and humility
- Mercenary = typically low on prescribing power, rep-camaraderie
- High-prescribers = strong personal connection, better gifts/grants
- Prefers competitor drug = understand/capture market niche/benign
- Acquiescent = gifts enhance social pressure and guilt, maintain illusion
- No see/time = detail/goodwill staff to advocate
- Thought Leader = from for allegiance/subtle not cheerleaders
- Reps scour offices for interests that can be used to establish a personal connection
- Physicians who refuse to see reps are detailed by proxy via emissaries
- Pharmaceutical gifting involves carefully calibrated generosity
- Companies monitor ROI by prescription tracking (prescribers ranked 1—10)
- IMS Health, Dendrite, Verispan, WK
- Links to AMA databases for identification provides approx $44 million to AMA
- Demographing 'slicing and dicing' identifies susceptibility to marketing efforts
- Prescribing value = opp plus + attitude +outside influence
- Segmentation includes - hidden gems/low value/growers/spreader/loyalist/niche
- Physicians view rep provision as convenient if not entirely reliable educational service
- 75% found info useful
- 9% thought very accurate (72% somewhat accurate)
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The cost of pushing pills: a new estimate of pharmaceutical promotion expenditures in the United States
Gagnon and Lexchin
PLOS
2008 |
- Absence of reliable data on industry's cost structures
- Amount spent on promotion vs R&D is the heart of the debate
- Industry claims
- More on R&D than promotional activities ($29.6 million vs $27.7 billion, 2004)
- Many concerns about accuracy of IMS data
- Compiles info through surveys of firms – underestimation to enhance image
- Excludes meeting costs and sponsored talks (120k to 371k in 2004, $1.9m)
- Excludes spend on seeding/phase 4 trials (75% managed by commercial)
- CAM data more accurate:
- Samples, detailing, DTCA, meetings, e-promotion, trials, advertising, unmonitored
- $57.5 billion/year total expenditure on physicians, $61,000/physician
- Companies spend twice as much on promotion as on R&D
- Confirms image of a marketing-driven industry
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Do doctors have a future?
Horton et al
The Lancet
2007 |
- 2005, year-long enquiry into state of medical professionalism produced with a definition
- 6 implications of professional values
- 19 recommendations made
- Critique showed professionalism greatly valued with asprations
- 9 further roadshows ran on 2006 and 2007 to stimulate debate: common themes:
- Being a doctor similar to other roles in the NHS
- Can professionalism be taught?
- How to assess professionalism?
- Leadership is failing and the profession is underselling itself
- NHS and doctors need to influence public policy and drive health reforms
- Final meeting conclusions in 2007:
- Doctors are less optimistic about their future than non-doctors
- Doctors want to debate prospects openly and energetically
- Professional values translate directly to quality and improvement of patient care
- Doctors feel dangerously disengaged and alienated
- Fiasco of 'Modernising Medical Careers'
- Paralysis of 'Connecting for Health'
- Rhetoric of patient choice initiatives
- Docs empowered by working as cross-disciplinary teams not discrete groups
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US campaign tackles drug company influence over doctors
McCarthy
Tha Lancet
2007 |
- $6m donation for national campaign to reduce influence of industry on US doctors
- In partnership with IMAP
- Will promote implementation of guidelines that ban/severely restrict promotion practices
- Ban all gifts
- Free meals
- Payment for travel/time at meetings
- Payment for online participation in CME
- Exclusion of anyone with financial relations from formulary and purchasing comms
- Free samples replaced with vouchers
- Ban on CME sponsored by industry (contribute to central fund)
- Such practices already adopted by Yale, Stanford, UOP
- Criticized for inhibiting free exchange of ideas and preventing revolutionary partnerships
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The influence of pharmaceutical companies
Messmer
JFP
2000 |
- Commentary that physicians are responsible for interpretation of industry information
- Purports that a doctor so easily influenced is naÏve
- Calls for allowing companies freedom to advertise as other business do
- Allows 1 15min visit/day
- Entertainment/meals is accepted in other forms of business marketing
- Rather than condemn advertising speech, should train physicians to be more discerning
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Key opinion leaders: independent experts of drug representatives in disguise?
Moynihan
BMJ
2008 |
- Specialists paid generous fees to 'peddle influence' on behalf of companies
- Command fees of:
- £3k/lecture
- $400/hr consulting rate
- $200/hr on clinical trials
- Some doctors earn >$25k/yr in consulting fees
- Use of KOLs is a global phenomenon as 'product champions'
- Firms have KOL development programmes and databases tracking KOL ROI
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Who pays for the pizza? Redefining the relationships between doctors and drug companies
Moynihan
BMJ
2003 |
- Entanglement is widespread and influences behaviour
- Prescribing habits influenced:
- Preferences for new products with no advantage over existing ones
- Decreased prescribing of generics
- Rise in scrip expenditure
- Irrational and incautious prescribing
- 'Systematic Bias' in sponsored science where industry-sponsored research more likely to draw favourable conclusions
- 16 types of 'entanglement' listed
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Doctor, do you have a minute?
Quan
Journal of Clinical Sleep Medicine
2007 |
- Do interactions create unacceptable conflict between fiduciary responsibility to the patient vs 'obligation' to manufacturers?
- Is rationale compelling to justify elimination of benefit of interactions/free choice?
- In some programmes, commercial sponsorship is the only viable mechanism for trainees
- Commercial sponsors ad adverts support many medical societies
- Reducing attendance/readership would impair dissemination of scientific information
- COI are inherent in practice of medicine and in society
- Stringent artificial controls that limit freedom and choice may have consequence of hampering educational process and impairing car
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Pharmaceutical company payments to physicians
Ross et al
JAMA
2007 |
- AMA recommends gifts of benefit to patients and <$100
- Legislation of mandatory payment disclosure >$100 in 5 states
- California, Maine, West Virginia, Minnesota, Vermont 2001—2005
- 11 further states proposed similar legislation in 2006
- No easy access and data of limited quality
- Vermont:
- 39 companies disclosed
- 14 physicians/company median
- $11,227 median total value per company
- 61% payments not released as designated trade secrets
- 75% disclosed payments missing information
- $2.18M publicly disclosed
- $177 median payment
- Largest proportion of payments for education
- 2416 payments >$1000
- 68% food
- 24% cash
- 4% books/grants
- Minnesota:
- 60 companies disclosed
- 18 physicians/company median
- $47,090 median total value per company
- $30.96M publicly disclosed
- $1000 median payment
- Largest payments for research
- 6238 payments >$100
- 46% unspecified
- 27% education
- 13% speakers
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Promotional methods used by representatives of drug companies
Schramm et al
Scandinavian Journal of Primary Health Care
2007 |
- GPs prescribe new, expensive drug even if no advantages over older alternatives
- Many GPs regard rep visits as efficient, expedient source of info
- Frequent contact seems strongly associated with irrational prescribing
- 47 GPs collated info on promo activities over 6mo:
- 1050 visits – 22.3 mean
- 38 companies
- 197 different drugs
- 1514 promotions = 1.4 promotions/visit
- Top 3 frequency of visits by area 1. CV (atorvastin) 2. NSAIDS 3. Antidepressants
- Frequency not associated with practice type
- Materials/techniques used/offered in visits
- 68% leaflets/books
- 53% proposals to improve therapy for a specific patient
- 48% samples
- 36% other gifts
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Overregulation of conflicts hinders medical progress
Stossel
Cleveland Clinic Journal of Medicine
2007 |
- Revolution in medicine and technology is largely result of partnerships between private companies, entrepreneurial scientists and clinicians
- Regulations to prevent COI may have the unintended consequence of slowing medical progress
- Disclosure/transparency is a euphemism for invasion of privacy
- Now an informant culture in which COI vigilantes scan for opportunities to embarrass
- Medical advances speak to a harmony of interests
- Attitudes about conflict are unfounded
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Has the hunt for conflicts of interest gone too far? YES
Stossel
BMJ
2008 |
- Transactions between pts, insurance companies, hospitals and docs encompass 85% of the medical marketplace yet do not count as COI
- Detailed disclosures and stringent prophylactic management are not in public interest
- COI movement maligns and demonises
- COI ideology
- Purports to promote scientific rigour yet is far from that itself
- Implies promotional info is not evidence-based
- Adverse outcomes based on financial COI are almost non-existent
- Medical advances are overwhelmingly positively driven commercially
- No evidence supports that detailing and gifting adversely affect patient care
- Attitudes and regulations are ill-founded and harmful to public interest in medical innovation
- COI scolding distorts and damages views of science and medicine
- Most docs realize that
- asceticism and utopian zeal for behavioural perfection produce nothing
- risk-taking entrepreneurs, motivated in part by profit, advance medicine
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Innovation and industry-academia interactions…
Vagelos
Cleveland Clinic Journal of Medicine
2007 |
- Every phase of development has potential for COI
- Adherence to established rules and practices can eliminate possibility of COI
- Should look for new ways to come together in mutually agreed forums
- Interactions are important:
- Necessary to discovery and development of new drugs, vaccines, devices
- Critical for scientific and educational info for physicians for patient care
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How to dance with porcupines: rules and guidelines on doctors' relations with drug companies
Wager
BMJ
2003 |
- Interactions can lead to ethical dilemmas
- Codes are developed by industry organizations but backed up by complaints procedures
- International guidelines
- Reliable, accurate, truthful, informative, balanced, up-to-date, substantiated
- WHO criteria for medicinal drug promotion
- IFPMA code of pharmaceutical marketing practice
- National codes
- ABPI: gifts <£6 and relevant to work, hospitality appropriately proportion (PMCPA runs complaints procedures)
- Medicines Aus: simple, modest, secondary to educational content
- PhRMA: similar to ABPI, further restrictions on travel and honoraria
- France: code de la sante publique; <E30 benefits with fines up to E75k and 2-year prison sentence
- Most codes prohibit prescription inducements
- Most doctor orgs offer guidance about research
- AAMC: 'Protecting subjects, preserving trust, promoting progress' documents
- ACP: guidelines revised 2002... general, "willing to have these arrangements generally known?"
- AAPP: code of ethics
- RCP: Faculty of Pharmaceutical Medicine has detailed guidance
- Regulatory authorities:
- FDA: requires companies to supply info about investigators interests when submitting a licensing application
- OIG: Guidance issued
- Editors and journals
- ICMJE: strengthened requirements on COI declarations in 2001
- Further dialogue between parties is needed
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Physicians and the pharmaceutical industry. Is a gift ever just a gift?
Wazana
JAMA
2000 |
- Medline search of 538 articles/studies about relationships – 29 used, database and 5 interviews
- >$11B/year spent in promotion and marketing; $5B to reps, $8—13k/physician/year
- 16 identified attitudes of physicians about interactions
- 16 evaluated effect of interactions on practitioner
- Types of interactions:
- Start in medical school
- Meet reps 4 times/month
- Frequency of benefits from meals eclipsed by honoraria from training to practice
- Residents receive 6 gifts/year
- Attitudes towards interactions:
- Equivocal that reps provide accurate info
- Believe reps prioritize promotion above welfare
- Deny gifts influence behaviour
- Effect of interaction:
- Impact non-rational prescribing, awareness and rapid prescribing of new drugs and decreased prescribing of generic drugs
- Exposure to reps highly associated with perception of benefits of interactions
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A better code for a better relationship
Williams and Adams
Can J
Gastroenterol
2006 |
- Code is not voluntary for member companies – adherence is a condition of membership
- Terms of business relationship with HC professionals should be transparent and beyond reproach
- Role of local pharma reps will evolve to provide ongoing education, relevant info on medicines and responses to questions the physician may have
- Physician-industry relationship is an integral part of the global healthcare system
- Physicians prescribe the medicines that are developed by the innovative pharma community
- The public must have every confidence the medicines prescribed to them are based on optimal drug therapy and the best intervention to treat/cure a diagnosed illness
- Paramount that physician be fully knowledgeable about new approved medicines, updated clinical evidence of existing medicines and new indications approved
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