Drug development cost estimates hard to swallow

Collier, Roger

doi:10.1503/cmaj.082040

Cited by 84 publications

(53 citation statements)

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“…On average, approximately US$800 million was spent in 2003 by pharmaceutical companies in order to bring one new drug to the market (74). With the rapid rising of costs for research and development in drug industries particularly in the cost of clinical trials, the average funds required had swelled to US$1.7 billion in 2009 (75). Although these are examples for pharmaceutical drugs, the use of e-cigarettes for therapeutic purposes needs to be proven as safe for human consumption.…”

Section: Resultsmentioning

confidence: 99%

Electronic cigarettes and indoor air quality: a review of studies using human volunteers

Abidin

Zulkifli

et al. 2017

Reviews on Environmental Health

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AbstractObjective:This paper is primarily aimed to review articles on electronic cigarettes (e-cigarettes) focusing on indoor air quality (IAQ) assessment that were conducted using human volunteers under natural settings that mimic actual vaping scenarios. Such studies may give a better representation of the actual potential exposure towards e-cigarettes emissions in indoor settings.Methods:A systematic literature search was conducted using PubMed search engine database. Search terms such as “electronic cigarette”, “e-cigarette”, “electronic nicotine delivery system”, and “indoor air quality” were used to identify the relevant articles to be included in this review. Articles that involved human volunteers who were asked to vape in natural settings or settings that mimic the actual vaping scenario were chosen to be reviewed. The search yielded a total of 15 published articles. Eleven articles were excluded due to 1) unavailability of its full-text (n=1), 2) did not involve human volunteers (n=5) and 3) did not involve an IAQ study (n=5). Four articles were critically reviewed in this paper.Results:From the four selected articles, two of the papers focused on the determination of nicotine level released by e-cigarettes whereas the other two covered IAQ parameters namely; particulate matters (PM), propylene glycols, formaldehyde, metals and polycyclic aromatic hydrocarbons (PAHs). Only two of the studies involved determination of biomarkers of exposure. The level of chemical contents released varied between studies. The differences in the brands of e-cigarette used, number of vapers recruited and the sensitivity of the methodologies employed in these studies may be the possible causes for such differences. However, studies using human volunteers conducted in a natural setting are more relevant to portray the actual exposure to vapors among e-cigarettes users and non-users compared to studies using a smoking machine/an exposure chamber. This is because such studies take into account the behavior of consumers and individual retention of nicotine. Such method will therefore avoid the possibility of overestimation in terms of exposures toward e-cigarettes users and non-users.Conclusion:There are limited e-cigarette studies on the impact of IAQ performed using human volunteers in natural settings. The available studies however, provided inconsistent scientific evidence on the actual exposure towards the vapor contents as unstandardized methodology were used in conducting such research. Therefore, there is a need to conduct IAQ studies in natural settings by using a standardized protocol in terms of the number of vapers recruited, the size of the indoor settings, the methods used in detecting and quantifying the contents and levels of emissions and the sensitivity of the equipment used in analyzing the contents. This will help in better utilization of the findings from such studies for the use of risk assessment of the exposures towards e-cigarette emissions. There is also a need to emphasize that it is the onus of the manufacturers in providing and proving scientifically sound safety claims for their products prior to commercializing it in the market.

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Section: Resultsmentioning

confidence: 99%

Electronic cigarettes and indoor air quality: a review of studies using human volunteers

Abidin

Zulkifli

et al. 2017

Reviews on Environmental Health

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“…Despite the significant time and costs invested in drug development, the reported success rate is only 8% [7,8]. To guide clinical researchers to better design clinical trials and potentially improve the likelihood of FDA approval, we studied the concerns addressed by the ODAC on rejected drug applications and identified factors associated with FDA approval.…”

Section: Discussionmentioning

confidence: 99%

“…In addition,these clinical studies require hundreds tothousands of patients and necessitate an average of 6 years to complete [6]. It is estimated that pharmaceutical companies spend an average of $1.7 billion dollars per drug from development to market approval [7]. Despite these investments, only 40% of drug applications submitted for consideration are approved [1,8,9].…”

Section: Introductionmentioning

confidence: 99%

Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

et al. 2014

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Background. Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. Methods. All applications referred to the ODAC from 2001 to 2012 were reviewed. Results. Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median 5 38%), and 19 applications used

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“…Some parts of the world like China, India, and Africa still traditional method of treatment are present and this concept is reviving again in modern practice [10]. New drugs cost a lot to bring it in market [11]. In this modern world it is need to work more on these traditional medicine and treatments [12].…”

Section: Introductionmentioning

confidence: 99%

Traditional Methods of Treatment of Rheumatoid Arthritis

Afzal¹,

Afzal²

2017

J Tradi Med Clin Natur

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Traditional medicine is getting popularity in current practice of all fields of medicine. Concept of organic food is also reemerging in world. Due to resistance against the common antibiotic, researchers are working more on traditional method of treatments. Rheumatoid arthritis is treated with NSAIDs, steroids and DMRDs. It is estimated that 60 to 90 percent people use alternative method of treatment for the symptoms of rheumatoid arthritis like pain and stiffness. Physiotherapy, Herbal medicine and chiropractic are very popular. Borage seed oil (borago officinalis), capsaicin, curcumin (diferuloyl methane), feverfew (Tanacetum parthenium), Flaxseed oil, H15 (extract of Boswellia serrata, olibanum), RA1 (standardized Ayurvedic formulation) and Reumalex arepopular herbal medicine that are used in rheumatoid arthritis. No doubt use of traditional medicine is increasing in modern world but the evidence of its effectiveness is required more research work and studies. Academic research program like master and doctoral degree can fulfill these gaps.

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Drug development cost estimates hard to swallow

Cited by 84 publications

References 0 publications

Electronic cigarettes and indoor air quality: a review of studies using human volunteers

Electronic cigarettes and indoor air quality: a review of studies using human volunteers

Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

Traditional Methods of Treatment of Rheumatoid Arthritis

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