Medical doctors driving medical research, an endangered ... doctors...PHARMA INDUSTRY • The Truth...
Transcript of Medical doctors driving medical research, an endangered ... doctors...PHARMA INDUSTRY • The Truth...
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Medical doctors driving medical research, an
endangered species in our Flemish
universities.
marc de broe
friday 24 januari
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Master in Medicine
Masters in Medicine: 2005-13: 583 (362-758)
General Practitioners: 32.0% Specialists: 65.0% Aspirant-IWT: 3.5 %
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KUL: 50.3% UGent: 28.4% UA: 14.1% VUB: 7.0%
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Medical doctors driving medical research
• Predoctoral:
• FWO-Aspirants, 3yr/3yr
• IWT-project, funding, wage, 4yr
• Research Scholarships, 2yr/2yr
• VIB int . PhD program
• Pre > Post:
• FWO: Clinical Doctorate Grants, 2yr part time to finalize a
PhD
• Postdoctoral:
• FWO: Fundamental Clinical Mandate, 5yr/5yr 50%
• FWO: Postdoctoral Investigator
• VIB
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Aspirants FWO
FWO, UA, UGent Isabelle Verbaeys, Gino Verwimp, Joseph Knapen,
December 2013
* Medical Sciences: Pharmacy, Medicine, Biomedicine ** Stable, notwithstanding decrease in success rate, budgetary reason
Total
number Medical
Sciences* 26% Number of MD
aspirants**
2005 161 42 14
2006 193 50 16
2007 209 53 17
2008 203 52 16
2009 211 55 17
2010 200 52 16
2011 202 52 16
mean 197/yr 51/yr 16/yr
RUG KUL
UA VUB
out of 64
out of 48
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Instituut Wetenschap Technologie (IWT)
M. Oleo – IWT - December 2013
Total number of applicants
Number of MD applicants
Number of successful applicants
2009 495 10 4 (40%)
2010 655 13 6 (42%)
2011 644 9 2 (22%)
2012 688 16 3 (18%)
2013 789 20 1 (5%)
Toegepast Biomedisch Onderzoek met een Primair Maatschappelijke Finaliteit
Budget 6,5 milj. Euro
Het TBM-programma wil op lange termijn bijdragen tot de implementatie van nieuwe
therapieën, specifieke preventieve maatregelen en diagnosetechnieken
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Vlaams Interuniversitair Instituut Biotechnologie (VIB)
• International PhD program since 2007
• Out of 8 selected young investigators 1 MD
• Six out of the 78 research team leaders are MD PhD’s.
Source : B Fiems ,VIB, Januari 2014
Onderzoeksmandaten - Research Scholarships (UA)
• 5-7 new mandates/year, not enough MD candidates
Source : G Verwimp Januari 2014
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FWO: toegekende mandaten aan artsen 1996-2011
FWO 2005, 2012
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FWO: toegekende mandaten aan artsen 1996-2011
Aspirant
PostdoctoraalonderzoekerKlinischedoctoraatsbeursFundamenteelklinisch
Input of MD’s into biomedical research is “limited”
Starters 3.5% of graduates in MM
IWT-VIB marginal
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Fundamenteel Klinisch Mandaat (FKM) 5y/5y MD PhD’s
• Het fundamenteel klinisch mandaat ondersteunt goed opgeleide artsen en onderzoekers die een volwaardige carrière binnen het translationeel onderzoek nastreven. De mandaten bieden de mogelijkheid om deeltijds te worden vrijgesteld van een klinische functie in functie van het onderzoek. Translationeel onderzoek is de schakel tussen het fundamenteel biomedisch onderzoek, van kapitaal belang voor elke vooruitgang, en het klinisch onderzoek, dat zich op patiënten richt. Betere diagnostiek, behandeling, preventie. Patient staat centraal.
• Too short , clinical pressure still remains
• How to replace a well functioning staff member can be a problem .?
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Master in Medicine
Masters in Medicine: 2005-13: 583 (362-758)
General Practitioners: 32.0% Specialists: 65.0%
Aspirant-IWT: 3.5 % (+/- 20 /year) Input of MD’s in Biomedical Research is “LIMITED”
266
235
184
219
218
269
316
370
352
382
123
97
83
110
123
120
147
169
213
213
110
82
58
63
49
74
85
83
111
108
60
37
38
27
29
24
28
44
55
55
559
451
363
419
419
487
576
666
731
758
0 100 200 300 400 500 600 700 800
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
KUL: 50.3% UGent: 28.4% UA: 14.1% VUB: 7.0%
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J Am Soc Nephrol Number of papers per million population 2000-2011
Impact Factor 8.98 (2012)
8
2000-2004
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Kidney Internationalz
Impact Factor 7.95 (2012 ) Number of papers per million population 2000-2011
2000-2004
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Nature Medicine
Impact Factor 24,03 (2012) Number of papers per million population 2000-2011
5
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Kidney Int
+ JASN
rank order
1
2
3
USA 4
5
Canada 6
Australia 7
8
9
10
11
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Nature
Medicine
rank order
11
1
10
USA 2
5
Canada 4
Australia 8
3
6
7
9
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The Netherlands
• 165 nephrologists - 30% in university hospitals
• Until recently (still majority)– nephrologists – PhD
• 3-5 papers in peer reviewed journals with high impact factor (6 best journals in nephrology),three as first author;
• Research funding
- NWO – fundamental research – predoc, postdoc
- diabetes, rheuma, ...
- faculties – postdoc for clinicians
- hospital clinical research
- EC
- NIH, others
- Nierstichting >>
• Nederlandse Vereniging Nefrologie – multicenter trials
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Nierstichting The Netherlands
INCOME (thousands of euros)
• Collection 4548
• Mailing actions 5286
• Legacies 4065
• Gifts 268
• Assoc. friends 488
• Sponsoring 287
EXPENSES (thousands of euros)
• Collection 383
• Mailing actions 2141
• Innovation in Care 109
• Prevention 3002
• Biomedical research 4550
• Social policy/patient care 1791
• Communication 2693
• Children with kidney disease 408
• Patient associations 774
• Staff-Personel 2709
• Travel 258
• Office 503 Extracted from: De Nierstichting Financial Report 2006 -2012
Ter Wee personal communication 2012
Total income 2006: 15 x 106 € 75% spent in research support
www.nierstichting.nl
Consortia (3 centra)
Innovative grants
Kolff program
2012 :17.9 milj Euros
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Number of MD’s starting a research carreer in Flanders is limited
and is decreasing .
Biomedical research in Belgium/Flanders is competitive
and remains so/ improving over the last 10years year due to
better funding and input from non – MD’s trained in biomedicine.
FWO is far out the best provider /controller of the current
clinical research mandates for MD’s
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The number, quality, and coverage of randomized controlled trials (RCTs) in internal medicine
Palmer SC et al: Am J Kidney Dis 58:335-337, 2011
Number of randomized controlled trials published in nephrology and 12 other specialties of internal medicine from 1966-2010
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Research: Erik Snelders
Design: Dirk De Weerdt
2009– 2013
analogue distribution
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Clinical Research (CR) Investigator (MD PhD) Driven
• Human resources
• Number of masters in medicine; increase in number of
masters in biomedical sciences
• Decrease of number of MDs research line carreer
• Work load in clinical departments - budgetary pressure
• Absence of stable long term carreer in CR
• Wage difference clinical -- biomedical research career
• Teaching – organization
• Insufficient teaching of CR at master MS level
• Insufficient funding and lack of infrastructure
• Increase in guidelines – administrative burden
• Monopoly of pharma industry in CR – Cost of RCTs
• Export of CT’s – developing countries
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Effect of Cinacalcet on Cardiovascular Disease in Patients
Undergoing Dialysis EVOLVE
The EVOLVE Trial Investigators
N Engl J Med 2012; 367:2482-2494
Cost ; 140 million US Dollar (internal ressources not included)
In an unadjusted intention-to-treat analysis, cinacalcet did not
significantly reduce the risk of death or major cardiovascular
events in patients with moderate-to-severe secondary
hyperparathyroidism who were undergoing dialysis
BONAFIDE RMP study
Bone histomorphometry before and after long-term
treatment with cinacalcet in dialysis patients with
secondary hyperparathyroidism (multicenter study)
Cost : 3.5 million US Dollar RMP: risk mangement plan (FDA-EMA)
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PHARMA INDUSTRY
• The Truth about the Drug Companies . How they deceive
us and what to do about it
• Marcia Angel Random House 2004
• Doubt is their Product . How indusrty ‘s assault on
science threatens your health
• David Michaels Oxford University Press 2008
• Bad Pharma . How drug companies mislead docters and
harm patients
• Ben Goldacre Fourth Estate 2012
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Pharma industry (PI)
clinical research “non transparent”
• Trial focus: registration – dominance of PI (85-95%)
• Unappropriate comparisons – doses – too high – too low
• Changing, primary—secundary , irrelevant end points
• Most trials are “me too” – “add on” –no “stop -trials
• Selection of normal subjects – aging? real life setting
• Commercialization of clinical trials (CRO*)
• “Education” of MDs, patient organization,
• Scientific boards, advisory boards
• Export of CR to developing countries
* Contract Research Organization
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7 October 2007 In a trend that has received little attention contract research organizations (CRO’s) have grdually taken over much of academ ic
role of drug development
US 30,000/patient
Romania 3,000 /patient
CEO Quintiles 2013
The constant gardenerr
Ethical committees , China 11% 2009
2013 R > 11
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Pharma industry – clinical trials
LACK of TRANSPARENCY
• Publication of positive results 70-85%
• Constraints on publication rights
• Ghost writing – redundancy – disaggregation
• Negative results <25% published
• Missing data – meta analysis – golden standard?
• Medical journals reprint business
• Regulators should have all the data , often don’t share it
NEED for INVESTIGATOR DRIVEN INDEPENDENT CT (RCT’s)
to FORM a COUNTERBALANCE to PHARMA-INDUSTRY
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The Antihypertensive and Lipid-Lowering Treatment to Prevent
Heart Attack Trial (ALLHAT) (1996-2004) NIH Clinical Center
• The study tried to find which was the best choice for starting
treatment. Results show that diuretics work best to both lower
blood pressure and prevent stroke and some forms of heart
disease, including heart attack and heart failure.
calcium channel blocker, an angiotensin converting enzyme
(ACE) inhibitor, and an alpha-adrenergic blocker
• In people with diabetes, diuretics work as well as ACE-inhibitors
and calcium channel blockers in protecting against heart attack
and improving survival, and offer more protection against
congestive heart failure.
• The latest findings from the "Antihypertensive and Lipid-
Lowering Treatment to Prevent Heart Attack Trial" or ALLHAT,
sponsored by the National Heart, Lung, and Blood Institute, are
published in the June 27 issue of Archives of Internal Medicine.
National Heart, Lung, and Blood Institute JAMA Arch Intern Med 2004-2008 …
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By Dennis Thompson
HealthDay Reporter
WEDNESDAY, Dec. 18, 2013 (HealthDay News) -- Fewer people should take medicine to control their high blood pressure, a new set of guidelines recommends
Fewer people should take medicine to control their high
blood pressure, a new set of guidelines recommends.
JAMA Editorial: "Recommendations for Treating
Hypertension: What Are the Right Goals-Purposes
(jama.jamanetwork.com)(Dec. 18, 2013)
Adults aged 60 or older should only take blood pressure medication
if their blood pressure exceeds 150/90, which sets a higher bar for
treatment than the current guideline of 140/90, according to the
report, published online Dec. 18 in the Journal of the American
Medical Association.
Review of “quality selected” RCT ‘s of the last 10years
Investigator driven unrelated to pharma -industry
Endless protest ………..
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WHAT CAN and SHOULD WE DO ?
• Improve teaching of clinical research – clinical pharmacology
• Create part and full time, long term, clinical research carreers for
qualified MD’s , competitive wages
• Funding at national ,preferable at EU level of clinical research centers
(US , UK…)
• Balance between clinical oriented investigator driven research and
contract research (pharma- industry …)
• Simplify regulatory bureaucracy , new EU regulations
• TRANSPARENCY
• NICE , Damocles, Sunshine act, ProPublica, NICE , Clinical Trial.gov ;
• Examples of potential funding ..
•
•
• De uitbouw van het translationeel ondezoek in Vlaanderen 2008
• Centrum voor Medische Innovatie 2009
• Commissie Wetenschappelijk Onderzoek KAGB 2008 2014
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TWO REALISTIC PROPOSALS ---- 2014
“HUMAN RESSOURCES “
• -- Fundamental Clinical Research Mandates FWO
• -- Clinical Research Centers
• clinical pharmacology
• Internationale Benchmarking van de Financiering van Translationeel
Onderzoek 2008 W Luyten
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Fundamenteel Klinisch Mandaat (FKM) 5y/5y MD PhD’s
• Het fundamenteel klinisch mandaat ondersteunt goed
opgeleide artsen en onderzoekers die een volwaardige
carrière binnen het translationeel onderzoek nastreven. De
mandaten bieden de mogelijkheid om deeltijds te worden
vrijgesteld van een klinische functie in functie van het
onderzoek. Translationeel onderzoek is de schakel tussen het
fundamenteel biomedisch onderzoek, van kapitaal belang voor
elke vooruitgang, en het klinisch onderzoek, dat zich op
patiënten richt. Betere diagnostiek, behandeling, preventie.
Patient staat centraal.
• Too short , clinical pressure still remains
• How replace a well functioning staff member?
1 --FKM’s as a carreer , preferable 50% , evaluation
procedure after 3 years
• 2 -- Increase the number of FKM ‘s
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CLINICAL RESEARCH CENTERS CLINICAL PHARMACOLOGY INVESTIGATOR DRIVEN NOT _INDUSTRY SUPPORTED CLINICAL RESEARCH
• Faculty of medicine- University hospital supported (RUG,UA,VUB,KUL)
• Multitask - teaching at graduate –post graduate level of CR
• - ethical committee , clinical rounds
• - protocol develp. ,methodology, analysis ,storage of data ,
• logistic support, follow up , publication ,administration
• - RCT ‘s investigator driven
• - industry supported cinical trials drugs …..devices
• COUNTERBALANCE for the monopoly pharma-industry
• Upgrade of the important aspect of patient related Clinical Research
•
• Counterbalance for monopoly of pharma-industry
• Upgrade of important aspect of patient related Clinical Research
•
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I Verbaeys FWO H Willems FWO G Hellenbosch FWO M Oleo IWT B Fiems VIB G Verwimp UA E Spruyt UA P D’Haese UA J Knapen KUL B Goodman Amgen J Mc Taggert Astra Zeneca Thanks
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Lancet 2010
2008
2007
2012
Probiotica
Torcetrapib (CP-529,414, Pfizer) was a drug being developed to treat hypercholesterolemia
Tissue plasminogen activator
Parasympathicomimeticum