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Cover page of the Journal of Health Sciences


 
 Table of Contents  
REVIEW ARTICLE
Year : 2018  |  Volume : 11  |  Issue : 2  |  Page : 108-110

The downsides of industry-funded development of new therapeutics


1 Clinical and Experimental Therapeutics, University of Georgia, Georgia, USA
2 Clinical Pharmacology Department, KIMS BIBI Hospital, Hyderabad, Telangana, India

Date of Web Publication18-May-2018

Correspondence Address:
Dr. Mir Shoeb Ulla Adil
University of Georgia, Georgia
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/kleuhsj.kleuhsj_164_17

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  Abstract 


Clinical trials are a series of studies that help evaluate the safety and efficacy of a newly discovered drug. Although government funds around 80% of basic research to discover new drugs, it does not sponsor clinical trials at a competent level. Most of the trials are financially supported by pharmaceutical companies which arecertainly a worthwhile contribution to drug discovery, but it also influences the outcome of a clinical trial by ensuring acceptable government policies. Studies revealed that industries often practice selective reporting where unfavorable results are concealed, and positive outcomes are over-published, thereby misleading policies and future research. These downsides can be countered by utilizing funds that are totally devoid of industrial interference. It was reported that medical practitioners widely accept results from government-funded research studies and degrade the integrity of industry-funded clinical trials. Government-funded clinical trials virtually result in flawless conclusions which are extensively accepted and employed in conducting future research. Unlike industry-funded research work, government-funded trials emphasize on the need of the hour and deliver a quality result which is witnessed by the emergence of 93 Nobel Prize winners through the National Institutes of Health funded research work. A survey study revealed that 68% of respondents endorsed for doubling government funds for drug development. Utilizing standard methodologies from health economics such as cost-effective analysis and health technology assessment and public–private collaborations can be a solution for several developing and underdeveloped countries which cannot afford to sponsor drug research on its own.

Keywords: Clinical research, clinical trials, drug discovery, funding, sponsor


How to cite this article:
Ulla Adil MS, Sultana R. The downsides of industry-funded development of new therapeutics. Indian J Health Sci Biomed Res 2018;11:108-10

How to cite this URL:
Ulla Adil MS, Sultana R. The downsides of industry-funded development of new therapeutics. Indian J Health Sci Biomed Res [serial online] 2018 [cited 2018 Aug 19];11:108-10. Available from: http://www.ijournalhs.org/text.asp?2018/11/2/108/232682




  Introduction Top


Clinical trials are a series of studies that help evaluate the safety and efficacy of a newly discovered drug. The outcome of these episodes erects a scientific foundation to treat diseases. An investigational new drug application (NDA) should be filed with the food and drug administration to commence a clinical trial which comprises three sequential phases with growth in sample size at every phase. Drug developers then file a NDA to obtain marketing approval for their drug.[1] The whole process is not only time-consuming but also expensive owing to the regulatory demands and strenuous guidelines.[2] Since the late 1990s, expenditures on developing pharmaceuticals has exceeded any other component of the healthcare system.[1] In 2003–2007, an average of 12.4 new molecule entities were required for each new approval of the drug. The figure risen to 30.4 during the years of 2007–2011, thereby elevating the cost of drug development.[2]

Government share in clinical trial funding

Although government funds around 80% of basic research to discover new drugs, it does not sponsor clinical trials at a competent level. Most of the trials are financially supported by pharmaceutical companies.[3],[4] A study revealed that 93.3% of drugs approved in the United States from 1990 to 1999 were funded by pharmaceutical industries while mere 3.2% were supported by government funds.[1]

Consequences of industry-funded clinical trials

Sponsorship from pharmaceutical companies is certainly a worthwhile contribution to drug discovery. However, the financial power can also influence the outcome of a clinical trial by ensuring acceptable government policies.[5] They could hesitate to refrain from using power in the research activity.[6] Studies from the past revealed that industry-funded trials concludes with a positive result far more often than research funded by other sources.[7],[8],[9] Djulbegovic et al. have reported that a higher rate of success in industry-funded research is a result of “uncertainty principle” violation. These studies also hinges on a comparison of the novel drug with a placebo rather than a reputed drug which has the potential to undermine the former.[9],[10],[11] These biases not only obscure the veracity but also direct physicians to follow a flawed therapy for their patients.[12]

Furthermore, variation in the publication of the clinical trial result is also reported. Several studies revealed that industries often practice selective reporting where unfavorable results are concealed, and positive outcomes are over-published, thereby misleading policies and future research.[9] von Elm et al. reported that the likelihood of publication was higher in studies funded by government sources than in industry-sponsored studies.[11],[12]

Not all companies are capable of funding research. Apart from abrupt ends to clinical trials, inadequate funds also lead to several other consequences such as mergers and possession of pharmaceutical companies which results in diminished innovation prospects as companies prefer to work on low-risk follow-on drug products. Furthermore, collaboration of companies escalates the prices of medicines in view of reduction in competition.[2],[6]

The aforesaid downsides can be countered by utilizing funds that are totally devoid of industrial interference.[13],[14] Achieving a positive result is not the only prerequisite for a clinical trial to be considered as successful, but the outcome should help the physicians and researchers in the treatment of diseases and future research work, respectively. This can be attained by conducting clinical trials funded by government organizations as it was reported that medical practitioners widely accept results from the government-funded research studies and degrade the integrity of industry-funded clinical trials.[4]

Government-funded clinical trials virtually result in flawless conclusions which are extensively accepted and employed in conducting future research. Federal research funding has led the foundation of many medical innovations. At present, the spending of the federal government on the National Institutes of Health (NIH) research is only 1% of its budget. Treatment of challenging diseases is only possible when there is a significant increment in fund allocation from the government to conduct research on novel therapeutics.[15] Unlike industry-funded research work, government-funded trials emphasize on the need of the hour and deliver a quality result which is witnessed by the emergence of 93 Nobel Prize winners through NIH funded research work.[2],[15] A survey study revealed that 68% of respondents endorsed for doubling government funds for the drug development.[15] Moreover, regulatory agencies such as the European Medicines Agency should be funded extensively to rescue them from the capture of industries.[3]


  Conclusion Top


The drawbacks mentioned in the present article can be countered by utilizing standard methodologies from health economics such as cost-effective analysis and health technology assessment that demonstrates the worth of novel medicine in terms of units of currency per health benefit achieved.[16] Public-private collaborations is a solution for several developing and underdeveloped countries which cannot afford to sponsor drug research on its own, thereby threatening the sustainability of research grants. This type of collaborations has more innovative potential than the individual partners and spread the risks among them without reducing the probability of developing a new medicine.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. J Health Econ 2003;22:151-85.  Back to cited text no. 1
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2.
Moors EH, Cohen AF, Schellekens H. Towards a sustainable system of drug development. Drug Discov Today 2014;19:1711-20.  Back to cited text no. 2
    
3.
Light DW, Lexchin JR. Pharmaceutical research and development: What do we get for all that money? BMJ 2012;345:e4348.  Back to cited text no. 3
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4.
Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med 2012;367:1119-27.  Back to cited text no. 4
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5.
Relman AS, Angell M. America's other drug problem: How the drug industry distorts medicine and politics. New Repub 2002;227:27-41.  Back to cited text no. 5
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6.
Lièvre M, Ménard J, Bruckert E, Cogneau J, Delahaye F, Giral P, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ 2001;322:603-5.  Back to cited text no. 6
    
7.
Krimsky S. Do financial conflicts of interest bias research? An inquiry into the “funding effect” hypothesis. Sci Technol Hum Values 2013;38:566-587. Doi: 10.1177/0162243912456271.  Back to cited text no. 7
    
8.
Davidson RA. Source of funding and outcome of clinical trials. J Gen Intern Med 1986;1:155-8.  Back to cited text no. 8
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9.
Chopra SS. MSJAMA: Industry funding of clinical trials: Benefit or bias? JAMA 2003;290:113-4.  Back to cited text no. 9
    
10.
Schott G, Pachl H, Limbach U, Gundert-Remy U, Ludwig WD, Lieb K, et al. The financing of drug trials by pharmaceutical companies and its consequences. Part 1: A qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials. Dtsch Arztebl Int 2010;107:279-85.  Back to cited text no. 10
    
11.
von Elm E, Röllin A, Blümle A, Huwiler K, Witschi M, Egger M, et al. Publication and non-publication of clinical trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 2008;138:197-203.  Back to cited text no. 11
    
12.
Sismondo S. Pharmaceutical company funding and its consequences: A qualitative systematic review. Contemp Clin Trials 2008;29:109-13.  Back to cited text no. 12
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13.
Barbieri M, Drummond MF. Conflict of interest in industry-sponsored economic evaluations: Real or imagined? Curr Oncol Rep 2001;3:410-3.  Back to cited text no. 13
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14.
Lexchin J. Sponsorship bias in clinical research. Int J Risk Saf Med 2012;24:233-42.  Back to cited text no. 14
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15.
Mack C. The Benefits of Medical Research and the Role of the NIH. Office of the Chairman; 2000. p. 1-56.  Back to cited text no. 15
    
16.
Cressman S, Browman GP, Hoch JS, Kovacic L, Peacock SJ. A time-trend economic analysis of cancer drug trials. Oncologist 2015;20:729-36.  Back to cited text no. 16
[PUBMED]    




 

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