Date post: | 06-Apr-2018 |
Category: |
Documents |
Upload: | parth-shastri |
View: | 234 times |
Download: | 0 times |
of 84
8/3/2019 Pharmaceutical Industry Ethics
1/84
The
PharmaceuticalIndustryFacts, Fiction, Policy and Ethics
Martin Donohoe
8/3/2019 Pharmaceutical Industry Ethics
2/84
Outline
Economics
Influences on PhysicianPrescribing
Academia-Industry Connection
Ethical and Policy Issues
8/3/2019 Pharmaceutical Industry Ethics
3/84
Prescription Drugs
10,000 FDA-approved drugs
70% of all officevisits lead toprescriptions
1.5 - 2.0 billionprescriptions/year
8/3/2019 Pharmaceutical Industry Ethics
4/84
Prescription Drugs and HealthCare Costs
>10% of U.S. medical costs>10% of U.S. medical costs
The fastest growing component of the $1.3trillion US health care bill
8/3/2019 Pharmaceutical Industry Ethics
5/84
Economics of the PharmaceuticalIndustry
Sales revenues tripled over lastdecade
Prices increased 150% (versus50% CPI)
Spending up 17% from 2000 to2001
8/3/2019 Pharmaceutical Industry Ethics
6/84
Economics of the PharmaceuticalIndustry
Worldwide sales > $145 billion/year
US = Largest market40 % of worldwide sales
Average CEO compensation = $20million (1998)
8/3/2019 Pharmaceutical Industry Ethics
7/84
Economics 16.4% profit margin in 2000 ($24
billion)
-Largest of any industry
-4 times greater than averagereturn of all fortune 500companies
-8 out of 25 most profitable U.S.companies are pharmaceuticalcompanies
8/3/2019 Pharmaceutical Industry Ethics
8/84
Economics of the PharmaceuticalIndustry
Greater than 5000 companiesworldwide
Less than 100 companiesaccount for over 90% ofworldwide market
8/3/2019 Pharmaceutical Industry Ethics
9/84
Mergers and Acquisitions
Drug company mergers
- Pfizer-Warner-Lambert- Upjohn-Pharmacia
Pfizer acquired Pharmacia in 2002 for$60 billion to become the worldsmost powerful drug conglomerate
8/3/2019 Pharmaceutical Industry Ethics
10/84
Drug Industry Lobbying
Pharmaceutical Research andManufacturers Associationpowerful lobby
623 lobbyists for 535 members ofCongress
8/3/2019 Pharmaceutical Industry Ethics
11/84
Drug Industry Lobbying
$38 million donated to Congressionalcampaigns in the 1990s
$84 million in 2000 election (2/3 toRepublicans)
Orrin Hatch (R-Utah) - $169,000 in 2000 - #1
John Ashcroft (Atty. Genl) - $50,000 in losing2000 Senate bid
GW Bush received $456,000 during his2000 election campaign
8/3/2019 Pharmaceutical Industry Ethics
12/84
Drug Costs
U.S. highest in the world
55% > Europe35% to 80% > Canada (drug companiesstill among the most profitable in Canada)
Cross border pharmacy visits increasingly
commonCanada vs. Mexico
8/3/2019 Pharmaceutical Industry Ethics
13/84
Drug Costs
U.S. only large industrialized countrywhich does not regulate drug prices
Single payer system woulddramatically decrease drug costs
Single purchaser able to negotiatedeep discounts
8/3/2019 Pharmaceutical Industry Ethics
14/84
Drugs: Who Pays?
55% out-of-pocket
25% private insurance
17% medicaid
3% Other (VA, Workmans Comp, IHS,etc..)
8/3/2019 Pharmaceutical Industry Ethics
15/84
Where Prescription Dollars Go
Research and development - 12%-preclinical testing - 6%
-clinical testing - 6% Manufacturing and distribution - 24%
Sales and marketing - 26%
Administrative / miscellaneous expenses -
12% Taxes - 9%
Net profit - 17%
8/3/2019 Pharmaceutical Industry Ethics
16/84
The Elderly and Prescription DrugCoverage
Elderly represent 12% of U.S. population,yet account for 33% of drug expenditures
Almost 2/3 of elderly Medicare enrolleeshave no coverage for outpatient drugs
sicker and poorer then their counterparts
with supplemental insurance.
8/3/2019 Pharmaceutical Industry Ethics
17/84
The Elderly and Prescription DrugCoverage
Drug expenditures increasing up to 10times as fast as SS and SSI benefits
1 out of 6 elderly Medicare patientsare poor or near poor (incomes less
than $7,309 or $9,316 respectively)
8/3/2019 Pharmaceutical Industry Ethics
18/84
Consequences of No PrescriptionDrug Coverage for the Elderly
Noncompliance, partialcompliance
Increased ER visits andpreventable hospitalizations,higher rates of disability, and
greater overall costs
8/3/2019 Pharmaceutical Industry Ethics
19/84
Consequences of No PrescriptionDrug Coverage for the Elderly
Elderly, chronically ill individuals
without coverage are twice aslikely to enter nursing homes
8/3/2019 Pharmaceutical Industry Ethics
20/84
The Elderly and Prescription DrugCoverage
Universal outpatient drug coverage cost-saving
-pharmaceutical industry stronglyopposed
-Citizens for Better Medicare (pharmaceuticalindustry front group) $65 million ad campaign todefeat a Medicare prescription drug plan in 2000
Bush/Congressional prescription drugbenefit proposals woefully inadequate
8/3/2019 Pharmaceutical Industry Ethics
21/84
Generics
Increased market share
-1983 = 15%-1993 = 40%-2000 = 42%
Average cost 1/3 of comparable
name-brand drug
8/3/2019 Pharmaceutical Industry Ethics
22/84
Generics
Brand name manufacturers acquiringgeneric producers
E.g., Merck-Medco
Prices rose almost twice as rapidly as
those of brand-name drugs in 2002
8/3/2019 Pharmaceutical Industry Ethics
23/84
Delaying Generic Competition
Nuisance lawsuits against genericmanufacturers
Lobbying for Congressional BillsExtending Patent Protection
Schering Plough / Claritin - $20 millionlobbying campaign
Big-name lobbyists (Howard Baker, CEverett Koop, Dennis Deconcini, LindaDaschle)
8/3/2019 Pharmaceutical Industry Ethics
24/84
Influences on PhysicianPrescribing Habits
Texts
Journals
Colleagues
Formularies
Samples
Patient requests Personal experience
Cost
8/3/2019 Pharmaceutical Industry Ethics
25/84
Influences on PhysicianPrescribing Habits
Gifts
Drug advertisements
Pharmaceutical representatives
8/3/2019 Pharmaceutical Industry Ethics
26/84
Gifts from PharmaceuticalCompanies
Pens, toys and puzzles
Household gadgets
Food
Books
Event tickets
Travel and meeting expenses Cash
8/3/2019 Pharmaceutical Industry Ethics
27/84
Patients Attitudes TowardPharmaceutical Company Gifts(Gibbons et al.)
200 patients, 270 physicians
1/2 of patients aware that doctorsreceive gifts
1/4 believe theirdoctor(s) accepted
gifts 1/3 felt costs passed along to patients
Patients felt gifts less appropriatethen did physicians
8/3/2019 Pharmaceutical Industry Ethics
28/84
8/3/2019 Pharmaceutical Industry Ethics
29/84
AMA Guidelines Re Gifts toPhysicians from Industry
No cash gifts
No gifts with strings attached
8/3/2019 Pharmaceutical Industry Ethics
30/84
AMA Guidelines Re Gifts toPhysicians from Industry
CME sponsorship money toconference sponsor, notparticipating physicians
Meeting expenses for trainees
funneled through institution
8/3/2019 Pharmaceutical Industry Ethics
31/84
8/3/2019 Pharmaceutical Industry Ethics
32/84
Pharmaceutical CompanyAdvertising Drug Samples
$8 billion/year in samples$8 billion/year in samples
Dispensed at 10%Dispensed at 10% -- 20% of20% ofvisitsvisits
8/3/2019 Pharmaceutical Industry Ethics
33/84
Drug Samples
Only of samples go to patientsOnly of samples go to patients
60% of pharm reps self60% of pharm reps self--medicatemedicate
50% of residents self-medicate,often using samples
early 1990s - benzos
2000 - SSRIS for depression,antihistamines for sleep
8/3/2019 Pharmaceutical Industry Ethics
34/84
Truthfulness in Drug AdsWilkes et al.
Ann Int Med 1992:116:912-9
10 leading medical journals
109 ads and all available references(82%)
3 independent reviewers
8/3/2019 Pharmaceutical Industry Ethics
35/84
Truthfulness in Drug Ads:FDA Requirements
True statements-effectiveness-contradictions-side effects
Balance
Instructions for use
Approved uses only
8/3/2019 Pharmaceutical Industry Ethics
36/84
Truthfulness in Drug Ads:Data
57% little or no educational value
40% not balanced
33% misleading headline
30% incorrectly called drug the agent
of choice 44% could lead to improper
prescribing
8/3/2019 Pharmaceutical Industry Ethics
37/84
Truthfulness in Drug Ads Higher percentage of ads misleading
in Third World
Many agents available OTC
Increased FDA oversight and
enforcement needed
8/3/2019 Pharmaceutical Industry Ethics
38/84
Doctors are Influenced byPharmaceutical Advertising and
Marketing
Prescribing patterns
e.g., Calcium channel blockers 1998: Trovan most promoted drug
in US; sales most ever for anantibiotic in one year; use since
limited by FDA due to liver toxicity
8/3/2019 Pharmaceutical Industry Ethics
39/84
Doctors are Influenced:
Formulary Requestsby P and T Committee Members(JAMA 1994;271:684-9)
Met with drug rep 3.4X more likely torequest companys drug
Accepted money to speak at symposia 3.9X
Accepted money to attend symposia 7.9X
Accepted money to perform company-sponsored research 9.5X
8/3/2019 Pharmaceutical Industry Ethics
40/84
Pharmaceuticals Sales RepsTechniques
Appeal to authority
Appeal to popularity
The red herring
Appeal to pity Dryden - Pity melts the mind
8/3/2019 Pharmaceutical Industry Ethics
41/84
Pharmaceuticals Sales RepsTechniques
Appeal to curiosity
Free food/gifts
TestimonialsTestimonials
Relationship building/face timeRelationship building/face time
8/3/2019 Pharmaceutical Industry Ethics
42/84
Pharmaceutical Sales RepsTechniques
Active learning reinforcement /change
Favorable but inaccurate statements
Negative comments re competitorsproducts
Reprints not conforming to FDAregulations
8/3/2019 Pharmaceutical Industry Ethics
43/84
Relating to Pharmaceutical Reps
Awareness of sales tactics
Learn about new agents/formulationsbeing developed and tested
Question them, ask for references
Evaluate quality of references
8/3/2019 Pharmaceutical Industry Ethics
44/84
Sources of Accurate and ReliableDrug Information
The Medical Letter
Peer-reviewed studies and
reviews Micromedex
Prescribers Letter
Large databases
-The Cochrane Collaboration
8/3/2019 Pharmaceutical Industry Ethics
45/84
Sources of Accurate and ReliableDrug Information
Textbooks
Facts andComparisons
AHFS DrugEvaluations
AMA Drug Evaluations
Conns Current
Therapy The FDA (sometimes)
Not PDR
8/3/2019 Pharmaceutical Industry Ethics
46/84
Direct to Consumer Advertising
Began in 1980, briefly banned 1983-85
Expenditures:$155 million1985
$356 million--1995
$1 billion--1998
$2.8 billion--2000
8/3/2019 Pharmaceutical Industry Ethics
47/84
Direct to Consumer Advertising
US and New Zealand only countries toallow prime time TV advertising
1989 - one drug achieved >10% publicrecognition
1995 - 13 of the 17 most-heavily marketed
2000 Schering-Plough spent more to
market Claritin than Coca-Cola Enterprisesand Anheuser Busch spent to market theirproducts
8/3/2019 Pharmaceutical Industry Ethics
48/84
Direct to Consumer Advertising:Use of Celebrities
Micky Mantle Voltaren
Bob Dole Viagra
Joan Lunden Claritin
Newman - Relenza
8/3/2019 Pharmaceutical Industry Ethics
49/84
8/3/2019 Pharmaceutical Industry Ethics
50/84
Pet Pharmaceutical Industry
$3 billion market
Examples:
Clonicalm (clomipramine) for separation anxietyin dogs
Anipryl (seligeline) for canine CognitiveDysfunction Syndrome
Sea pet shark cartilage treats for doggie
arthritis Pet superstores and websites sell multiple
antibiotics
8/3/2019 Pharmaceutical Industry Ethics
51/84
Pharmaceuticals on the Farm:Agricultural Antibiotic Use
Agriculture accounts for 70% ofU.S. antibiotic use
Use up 50% over the last 15years
Due to explosion in factory
farming
8/3/2019 Pharmaceutical Industry Ethics
52/84
Consequences of AgriculturalAntibiotic Use
CDC: Antibiotic use in food animalsis the dominant source of antibiotic
resistance among food-bornepathogens.Campylobacter fluoroquinolone
resistance
VREF (poss. due to avoparcin usein chickens)
8/3/2019 Pharmaceutical Industry Ethics
53/84
The FDA: Current Issues
Nicotine/Cigarette regulation
Policies re transgenic foods (GMOs,
Frankenfoods) Biopharming
Pharmaceutical industry involvementin research and production of
chemical and biological warfareagents and drugs used to facilitateexecutions
8/3/2019 Pharmaceutical Industry Ethics
54/84
Policy Issues Related to WomensHealth Care Drugs
OCPs available OTC
PharmacistPharmacist--prescribed emergencyprescribed emergencycontraceptioncontraception
reduce number of unintendedreduce number of unintended
pregnanciespregnanciescost saving to patients and health carecost saving to patients and health care
systemsystem
8/3/2019 Pharmaceutical Industry Ethics
55/84
Concerns Re Research in the U.S.
22% of new drugs developed overthe last 2 decades new molecular
entitiesMost are me too drugs
Examples
8/3/2019 Pharmaceutical Industry Ethics
56/84
Concerns Re Research in the U.S.
Insurance coverage of clinical trialsdecreasing
Low enrollment causing delays inevaluating cancer medications
Clinical trials a stop-gap source ofcare / meds for poor and uninsured
8/3/2019 Pharmaceutical Industry Ethics
57/84
Unethical placebo-controlledtrials
anti-depressants
anti-psychoticsanti-emetics
anti-hypertensives
anti-inflammatories
8/3/2019 Pharmaceutical Industry Ethics
58/84
Pharmaceutical CompanyResearch
90% of health research dollars arespent on the health problems of 10%
of the worlds populationresearch on major diseases of the
developing world under-funded, notprofitable
8/3/2019 Pharmaceutical Industry Ethics
59/84
Pharmaceutical CompanyExperimentation
Third World experimentation withinappropriate placebo-controls:
AIDS drugs/Africa;Sulfazyme/Brazil
Results more beneficial to First
World patients
8/3/2019 Pharmaceutical Industry Ethics
60/84
Anti-AIDS Drug Availability in
Africa
36 million infected with HIV; 2/3 insub-Saharan Africa (1.3% of
global pharmaceutical market)Only 1/1000 S. African AIDSpatients getting anti-HIV drugs
8/3/2019 Pharmaceutical Industry Ethics
61/84
Anti-AIDS Drug Availability in
Africa
PHRMA lawsuit vs South Africa (supportedby US govt)
parallel importingcompulsory licensing
dropped after activist campaign
PHRMA continues to lobby against parallel
importing and compulsory licensingthrough governments and the WTO
8/3/2019 Pharmaceutical Industry Ethics
62/84
Third World Donations (Dumping) ofPharmaceuticals
Genuine gifts
Dubious gifts
clear out stocks of nearly-expireddrugs/poor sellers
tax write-offs (up to 2x productioncosts)
8/3/2019 Pharmaceutical Industry Ethics
63/84
Third World Donations (Dumping)
of Pharmaceuticals
Egregious Examples:-Expired Ceclor to Central Africa-Garlic pills and TUMS to Rwanda
-50% of donations to Bosnia expired ormedically worthless
Donation recommendations from WHO:
-WHO list of essential drugs-Expiration date at least 1 year away
8/3/2019 Pharmaceutical Industry Ethics
64/84
Academia/Pharmaceutical Industry
Links Strong/Growing
Industry funds 8-40% ofuniversity research (a 7-fold
increase since 1970) of scientific investigators have
industry affiliations
8/3/2019 Pharmaceutical Industry Ethics
65/84
Academia/Pharmaceutical Industry
Links Strong/Growing
2/3 of academic institutions holdequity in start-ups that sponsor
research at the same institutions Up to 80% of science and
engineering faculty perform
outside consultations
8/3/2019 Pharmaceutical Industry Ethics
66/84
Exclusive university - corporate
agreements
MIT 5 yr, $15 million deal with Merck and Co.for patent rights to joint discoveries
DFCI Novartis
UC Berkeley Novartis
Wash U. in St Louis - Pharmacia
Univ. of CO Ribazyme
BIH - Pfizer MGH - Shiseido
8/3/2019 Pharmaceutical Industry Ethics
67/84
Guidelines
Majority of authors of Clinical Practice
Guidelines published in major journalshave industry ties
Authors of NEJM reviews and editorialscan accept up to $10,000/year in speakingand consulting fees from each companyabout whose products they are writing
8/3/2019 Pharmaceutical Industry Ethics
68/84
Problems Consequent to Increased
Academia-Industry Partnerships
Impaired sharing of knowledge, materials
Difficulties in repeating/verifying importantresearch
Impaired collaboration
Driven by usual academic competitivejealousies, fears of contract violations andsubsequent litigation, and desire to protectfinancial interests and keep stock prices high
Patents used to inhibit other investigatorsresearch
8/3/2019 Pharmaceutical Industry Ethics
69/84
Educational Concerns RegardingIndustry-Funded Research
Diversion of faculty away from teaching,
towards more remunerative consultations
Faculty change research direction
Fellows/post-docs diverted to industry-related topics
Patent- and profit motive-related-publication delays affect trainee and juniorfaculty career development
8/3/2019 Pharmaceutical Industry Ethics
70/84
Withholding of Data / Publication
Delays / Harassment of Researchers
JAMA Celebrex (Pharmacia) study: fewerulcers than ibuprofen at 6 months, but nodifference at one year (only 6 month datasubmitted and published
Synthroid study: Betty Dong, UCSF,Boots/Knoll Pharmaceuticals
Deferipone: Nancy Oliveri, Universityof Toronto, Apotex
8/3/2019 Pharmaceutical Industry Ethics
71/84
Issues in Drug Company Research
60% of industry-sponsored trialsare contracted out to for-profit
research firms, which in turn maycontract with for-profit NIRBs forethical review
*Conflict of interest
8/3/2019 Pharmaceutical Industry Ethics
72/84
Proliferation of Physician
Researchers
3-fold increase in the number ofphysicians conducting research in
the last decade
Investigators can make from $500to $6000 per enrolled subject
Active recruiters can make from$500,000 to $1 million per year
8/3/2019 Pharmaceutical Industry Ethics
73/84
Seeding Trials
Sponsored by sales and marketingdept., rather than research division
Investigators chosen not for theirexpertise, but because they prescribecompetitors drug
Up to 25% of patients enrolled in
clinical trials
8/3/2019 Pharmaceutical Industry Ethics
74/84
Seeding Trials
Study design poor
Results rarely published
Disproportionate amount paid forinvestigators work (writing aprescription)
8/3/2019 Pharmaceutical Industry Ethics
75/84
Recommendations for Industry-
Sponsored Research
Written agreements with university, notresearcher
Alternatives therapies selected based onclinical relevance
Stepwise project results not provided tosponsor until study is funded and openpublication guaranteed
8/3/2019 Pharmaceutical Industry Ethics
76/84
Recommendations for Industry-
Sponsored Research
Full disclosure of conflicts of interest
No gag clauses regarding publication
Investigator not to act as consultant duringstudy
National/international database of clinicaltrials
8/3/2019 Pharmaceutical Industry Ethics
77/84
The Pharmaceutical Industry and
Medical Ethics
Funding of conferences, Centers ofEthics, individual investigators
E.g., $1 million gift from SmithKlineBeecham to Stanford UniversityCenter for Biomedical Ethics
Rapid growth of for-profit non-
institutional review boards (NIRBs) Ethicists for hire
8/3/2019 Pharmaceutical Industry Ethics
78/84
The Pharmaceutical Industry and
Medical Ethics
Ethics consultants serving on corporateboards
E.g., Harold Shapiro continued to drawannual directors salary from DowChemical while serving as Chair of NBAC
Loss of appearance of independence;damage to credibility
Most bioethics journals do not requireconflict of interest disclosures
8/3/2019 Pharmaceutical Industry Ethics
79/84
Increasing Involvement of Industry in
Provision of Continuing MedicalEducation
1/2 of the $1.1 billion spent on CME in 1999from industry
Medical Education and CommunicationCompanies
Sponsored/paid mainly by drugcompanies
Provide educational materials gratis
8/3/2019 Pharmaceutical Industry Ethics
80/84
Guidelines for Speakers at
Industry-Sponsored Events
Educational, not promotional
Content based on scientificdata and clinical experience
Full disclosure ofrelationship with companyand honoraria
Travel expenses not lavish
*Few mechanisms forsurveillance/guidelineenforcement *
8/3/2019 Pharmaceutical Industry Ethics
81/84
Enhancing Cooperation Between
Physicians and the PharmaceuticalIndustry
Improve compliance
Decrease adverse events Promote and fund of open, freely-
shared basic science and clinicalresearch, with appropriate but not
excessive compensation to thesponsoring investigator, institutionand company
8/3/2019 Pharmaceutical Industry Ethics
82/84
Conclusion
Pharmaceuticals andBiotechnology Industries
-Tremendous contributions tohealth-Motivation = alleviate suffering-Primary responsibility = makemoney for shareholders
8/3/2019 Pharmaceutical Industry Ethics
83/84
Suggestions
Be aware of worrisome trends in thebusiness of drugs, research and
health care Thoughtfully consider your
relationship with pharmaceuticalcompanies
Advocate locally and nationally forsolutions
8/3/2019 Pharmaceutical Industry Ethics
84/84
Contact Information
Public Health and Social JusticeWebsite
http://www.phsj.org