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Health Benefits of Nutraceuticals

Health & Fitness

Economic development of the people has improved their lifestyle. But the challenge that has arisen with this lifestyle change is increasing the prevalence of ‘lifestyle diseases.’ Lifestyle diseases refers to diseases associated with bad lifestyle choices including food habits. The increased trend of eating junk food is known to be the reason for several diseases (obesity, cardiovascular diseases) and nutritional deficiencies. Due to high cost of treatment of these diseases in the modern science, people have started looking for alternative or complementary treatment options. Thus, nutraceuticals came into focus and are being opted as they fulfill nutritional requirements and have therapeutic benefits.

The word “nutraceutical” was coined from “nutrition” and “pharmaceutical” by Stephen De Felice, founder and chairman of the Foundation for Innovation in Medicine in 1989. It is defined as “a food or parts of food that provide medical or health benefits, including the prevention and treatment of disease”.  Nutraceuticals are the pharmaceutically blended products that have both nutritional as well as the medicinal value. This type of product is designed to improve the physical health, and fight against day-to-day challenges such as stress, increase longevity, etc. It is a food supplement that plays a vital role in maintaining a healthy body and provides necessary supplements required for various metabolic processes to regulate body functions and thus protects the body from disease.

According to a Mordor Intelligence Report, the global nutraceuticals market is predicted to reach $671.30 billion by 2024.

Classification of nutraceuticals:

Nutraceuticals can be organized in several ways, depending upon its application and easier understanding. Some classifications can be based on academic instruction, clinical trial design, functional food development or dietary recommendations.

  • Based on food availability, they are divided into traditional nutraceuticals, obtained from nature directly, without any changes in the natural form and non-traditional nutraceuticals, foods enriched with supplements or biotechnologically designed crops to boost the nutrients
  • Based on mechanism of action, they are further classified with respect to specific therapeutic properties such as anti-microbial, anti-inflammatory, and antioxidants
  • Based on chemical nature, these are segmented depending upon their primary and secondary metabolite sources such as isoprenoid derivatives, phenolic substances, fatty acids, carbohydrates, and amino acid-based substances.

Nutraceuticals and their health benefits

Nutraceuticals are known to have therapeutics effects and physiological benefits. They are known to provide protection against various diseases including cardiovascular, obesity, diabetes, cancer, chronic inflammatory disorders, and degenerative diseases. Some of the food sources used as nutraceuticals and their therapeutic effects are discussed below:

  • Dietary Fibre– Dietary fibres are not hydrolysed by enzymes secreted by the digestive tract but by microflora in the gut. The benefits of consuming dietary fibres include the retardation of emptying of the gastric juices in the stomach thereby affecting the rate of digestion and the uptake of nutrients, and it improves glucose tolerance and lowers the risk of coronary heart disease, stroke, hypertension, diabetes, obesity and certain gastrointestinal (GI) disorders. Also, an increase in the intake of high fibre food improves serum lipoprotein values, lowers blood pressure level, improves blood glucose control for diabetes, and aids weight loss.
  • Probiotics– Probiotics are non-pathogenic, non-toxic anti-bacterial substances. These are resistant to gastric acid and adhere to gut epithelial tissues. Consumption of probiotics decreases the risk of systemic conditions like allergy, asthma, cancer, several infections of the ear and urinary tract. It is also used to treat GI conditions such as lactose intolerance, acute diarrhoea and antibiotic-associated GI side effects.
  • Prebiotics– It improves lactose tolerance, has anti-tumor properties, is capable of neutralizing toxins, stimulates the intestinal immune system, and helps reduce constipation, blood lipids and maintains safe blood cholesterol levels.
  • Polyunsaturated fatty acids (PUFAs) – These are very essential for all bodily functions and hence known as “essential fatty acids”. It can be only taken through diet. Omega-3-fatty acids are one on the best examples of PUFAs. The three major effects against cardiovascular diseases are anti-arrhythmic, hypolipidemic and antithrombotic. Its benefits are numerous, such as, it can help improve the health of pre-mature infants and patients suffering from asthma, bipolar and depressive disorders, dysmenorrhea and even diabetes. Infant formulas of omega-3-fatty acids nowadays contain docosahexaenoic acid (DHA) along with arachidonic acid, which closely mimic the breast milk. The FDA recommends a maximum of 3g/day intake of eicosapentaenoic acid (EPA) and DHA omega-3 fatty acids, with no more than 2g/day as a dietary supplement.
  • Antioxidant vitamins– Vitamins like vitamin C, vitamin E, and carotenoids are collectively known as antioxidant vitamins. These vitamins are self-sufficient and have synergistic effects. They prevent oxidative reactions leading to several degenerative diseases including cancer, cardiovascular diseases, cataracts etc.
  • Polyphenols– It has antioxidant, anti-inflammatory, anti-microbial, cardioprotective activities and plays a role in the prevention of neurodegenerative diseases and diabetes mellitus. Also, dietary polyphenols are believed (from in vitro studies) to affect numerous cellular processes like gene expression, apoptosis, platelet aggregation, intercellular signalling that can have anti-carcinogenic and anti-atherogenic implications.
  • Spices– These are responsible for lowering of blood cholesterol, prevention, and dissolution of cholesterol gallstones, protection of erythrocyte integrity in hypercholesterolemic condition, hypoglycaemic potential, amelioration of diabetic nephropathy. It also possesses antioxidant effect, anti-inflammatory and anti-arthritic effect, antimutagenic effect/cancer preventing, digestive stimulant action and antimicrobial activity.

People are trying to attain a healthier and a better quality of life by eating more vegetables, fruits, and other plant extracts, taking dietary supplements or nutraceuticals. The development of nutraceuticals and functional foods delivers unique products to the world at large and helps in enhancing consumer confidence. Nutraceuticals are substances that have physiological benefits or provide protection against chronic diseases. They are used to improve health, delay the aging process, prevent chronic diseases, increase life span, or support the structure or functions of the body.

Pharmacovigilance

Medical Writing

The term ‘pharmacovigilance’ was coined in the mid 70’s by a group of French pharmacologists and toxicologists to describe the operations encouraging evaluation of the risks and side effects potentially associated with drug treatment.(1, 2)The World Health Organization (WHO) defines pharmacovigilance as, ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’(3) It incorporates the processes involved in monitoring and evaluating adverse drug reactions viz., collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, blood products, herbals, vaccines, medical device, traditional and complementary medicines, with an aim to identifynew information about hazards and figuring out ways to safeguard patients from any potential harm.(2, 4)

Pharmacovigilance aims to:

    • Improve patient care and safety in relation to the use of medicines
    • Improve public health and safety in relation to the use of medicines;
    • Detect problems related to the use of medicines and communicate the findings in a timely manner.
    • Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefit.
    • Encourage the safe, rational and more effective use of medicines.
    • Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public(5)

Pharmacovigilance Setup
A typical setup for pharmacovigilance studies includes people from various organizational units, people at various levels colluding to prevent drug related problems and thereby decreasing morbidity/ mortality rates. Figure 1 depicts the various functions of each party involved in a pharmacovigilance setup.(2)


Operational Overview
The process of pharmacovigilance begins with safety information coming in fromvarious sources, followed by processing and assessment of these reports to their relationship with the investigational product, and submission of the compiled report to the concerned regulatory authorities.Figure 2 summarizes the major activities associated with pharmacovigilance.(6)


Type of Data Collected
According to the, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline E2D, two types of safety reports are distinguished in the post-authorization phase, viz.,
a) Unsolicited Reports
b) Solicited Reports
Table 1 enlists the types of reports included in both the categories.(7)Table 1: Classification of Safety Reports [Adapted from: Good Pharmacovigilance Guideline Module VI (7)]

Data Collection Methods
The process of data collection in a pharmacovigilance setup is broadly of 3 types:
1.Passive data collection
2.Mandatory data collection
3.Active data collection

1.Passive Data Collection
Passive data collection also known as voluntary case reporting, involves active participation by health care providers in reporting adverse reactions and medication errors.

2. Mandatory data collection
Mandatory data collection is when manufacturers and pharmaceuticals must report information on adverse reactions gathered during post-marketing surveillance to the health authorities as per the country regulations.

3. Active data collection
Active data collection is a focused and structured data collection activity involving use of various tools such as trigger tools, patient chart audits, and direct observation methods.(8)

Data Collection Tools
Adverse drug reactions and medication errors are generally collected by filling a standardized form. For countries with a national pharmacovigilance program (e.g., India), the reporting forms are generalized throughout thecountry.(8) These are collected in different databases. For example, Adverse Event Reporting System (AERS), Eudravigilance, Vigiflow, etc.(9)
Figure 3 provides a country-wise list of database and adverse drug report forms.


Figure 3: Country-Wise Database and Adverse Drug Report Forms [Adapted from: Kumar A. et al.,(9)]
Data MiningData mining is the process of searching big data sets for interesting or useful information.(10) Data mining is used in the construction of literature-extracted knowledge databases as well as a method for detecting new potential drug interactions. Information retrieval and natural language processing (NLP) techniques are frequently used in data mining. (11)It also provides an “early warning system” to help identify drug safety issues. (12)
Many methods have been developed for data mining drug safety signals (early hints suggesting the possibility of adverse events) in pharmacovigilance, such as disproportionality analyses, text mining, natural language processing, change-point analysis, geographical information systems technology, visualization tools, etc.(13, 14)The most common of them are viz.,

a)Disproportionality Analyses
b)Text Mining(12)
a)Disproportionality Analyses

Disproportionality analyses is primarily used for data mining spontaneous reporting system (SRS) databases. It makes use of statistical methods such as, proportional reporting ratio (PRR) and multi-item gamma poisson shrinker (MGPS) to compare the observed count of a drug-adverse event combination with a background count for the adverse events for all other drugs or drug combinations in the database. (12, 14) Several software programs generate PRR and/or MGPS scores such as Empirica Signal™, PV-Analyser™, Molecular Analysis of Side Effects [MASE™], Empirica Study™, JReview™, and Statistical Analysis Systems (SAS™). (14)
b)Text Mining
The large volume of “unstructured” or “narrative” data submitted in the reports such as event descriptions or narratives in electronic health records, medical literature, social media, or the internet, require analysis with the help of ‘text mining’.(12)Vaccine Adverse Event Text Mining (VaeTM) system, search and retrieval framework (SARF), Linguamatics™ I2E, Georgetown Vaccine Information and Safety Resource (G-VISR) tool, MedWatcher Social, SAS Enterprise Miner™, etc., are the various tools used to perform text mining. (14)
Figure 4 describes the data mining methods used for different types of data.


Figure 4: Data Mining Tool for Different Types of Data[Adapted from: DuggiralaHJ. et al., (14)]New Trends in Pharmacovigilance
The current trends followed in the pharmacovigilance industry are elaborated below;

  • Contract outsourcing to increase operational efficiency
  • Use of secondary data sources that contribute to widespread adverse drug reaction reporting
  • Cloud-based reporting to bring a robust global database of adverse drug reactions accessible to all
  • Big data technologies to protect and assimilate huge amounts of information
  • Use of data analytics to improve data utilization
  • Automation in the pharmacovigilance process to increaselabor efficiency
  • Artificial intelligence to overcome the drawbacks with traditionalpharmacovigilance services

Social Media and Pharmacovigilance
The Internet and social media has changed people’s mindset in relation to health care. According to the Pew Research Center’s Internet & American Life Project 2013, 72% of internet users admitted looking online for health information of some kind. (15) Social networks, forums and blogs have become a major platform for patients to share their therapy experiences, including adverse drug reactions. (16) Reports from social media sources are much rapid, occurring in close proximity to the event and are potentially richer sources than those reported through healthcare professionals. (17)
Figure 5 describes the ways in which pharmacovigilance teams can use social media to participate and enhance product safetyawareness.


HCP, Health Care Professional; PV, Pharmacovigilance.
Figure 5: Use of Social Media to Engage and Improve Awareness About Product Safety[Adapted from: The Impact and Use of Social Media in Pharmacovigilance (17)]The ICH-GVP, Council for International Organizations of Medical Sciences (CIOMS) Guidelines and the US FDA Guidelines provide guidance to the pharmaceutical industry for development and implementation of their social media strategies for pharmacovigilance. (7, 18, 19).Benefits of social media in pharmacovigilance are listed below (Figure 6).

HCP, Health Care Professional.
Figure 6: Benefits of Social Media on Pharmacovigilance[Adapted from: The Impact and Use of Social Media in Pharmacovigilance (17)]

Conclusion
Pharmacovigilance is an important discipline in managing adverse reactions of healthcare products.(20) It is based on the qualitative and quantitative research of reports of spontaneous adverse drug reactions, followed by a clinical evaluation of its effect on the drug’s general safety profile. Pharmacovigilance can promote public health programs by offering continuing information throughout the life cycle of a product, enabling a precise, reliable and balanced evaluation of the product’s risk-benefit ratio as more and more information becomes accessible with its use. (21) Pharmacovigilance’s fundamental goal is the secure use of drugs, safety of patients, and the protection of public health. To achieve this goal, national regulators and international organizations should be empowered to report more adverse reactions to health care professionals and the public.

References
1.McBride WG. Thalidomide and congenital abnormalities. Lancet. 1961;2(1358):90927-8.
2.Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: An overview. Online journal of public health informatics. 2015;7(2).
3.Pharmacovigilance 2019 Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/.
4.Pharmacovigilance: Ensuring the Safe Use of Medicines – WHO Policy Perspectives on Medicines2004 19 July 2019. Available from: http://apps.who.int/medicinedocs/en/d/Js6164e/.
5.The safety of medicines in public health programmes: Pharmacovigilance an essential tool. 2006. Available from: https://apps.who.int/iris/bitstream/handle/10665/43384/9241593911_eng.pdf.
6.Gagnon S, Schueler P, Fan JD. Pharmacovigilance and risk management. Elsevier; 2012. p. 141-59.
7.EMA. Guideline on good pharmacovigilance practices (GVP) Module VI2017 22 July 2019. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf.
8.Pharmacovigilance. 2012 [cited 22 July 2019]. In: Management Sciences for Health [Internet]. [cited 22 July 2019]; [35.1-.19].
9.Kumar A, Khan H. Signal Detection and their Assessment in Pharmacovigilance. Open Pharmaceutical Sciences Journal. 2015;2(1).
10.Hand DJ, Blunt G, Kelly MG, Adams NM. Data Mining for Fun and Profit. Statistical Science. 2000;15(2):111-26.
11.Vilar S, Friedman C, Hripcsak G. Detection of drug–drug interactions through data mining studies using clinical sources, scientific literature and social media. Briefings in bioinformatics. 2017;19(5):863-77.
12.Ventola CL. Big Data and pharmacovigilance: data mining for adverse drug events and interactions. Pharmacy Therapeutics. 2018;43(6):340.
13.Hauben M, Madigan D, Gerrits CM, Walsh L, Van Puijenbroek EP. The role of data mining in pharmacovigilance. Expert opinion on drug safety. 2005;4(5):929-48.
14.Duggirala HJ, Tonning JM, Smith E, Bright RA, Baker JD, Ball R, et al. Use of data mining at the Food and Drug Administration. Journal of the American Medical Informatics Association. 2015;23(2):428-34.
15.Fox S, Duggan M. Health online 2013. Health. 2013;2013:1-55.
16.Lengsavath M, Dal Pra A, de Ferran A-M, Brosch S, Härmark L, Newbould V, et al. Social media monitoring and adverse drug reaction reporting in pharmacovigilance: an overview of the regulatory landscape. Therapeutic innovation regulatory science. 2017;51(1):125-31.
17.The Impact and Use of Social Media in Pharmacovigilance2018. Available from: https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf.
18.Administration; FD. Good pharmacovigilance practices and pharmacoepidemiologic assessment. Center for Drug Evaluation Research. 2005.
19.V. CWG. Current Challenges in Pharmacovigilance: Pragmatic Approaches: Report: CIOMS; 2001.
20.Nour S, Plourde, G. Pharmacovigilance. 2019. In: Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety [Internet]. [7-23].
21.Nour S, Plourde, G. Conclusion. 2019. In: Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety [Internet]. [137-8].

Biosimilars: Advantages & Challenges

Publication Writing, , , , ,

Introduction

A biosimilar product, as defined by USFDA, is “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” By 2020, the biosimilar market is expected to reach $15 billion booming market, which is thrice the presentmarket(Ragunadhan 2018).Latest additions to this category of drugs are Hadlima(adalimumab-bwwd), Ruxience (rituximab-pvvr), Zirabev (bevacizumab-bvzr) and Kanjinti (trastuzumab-anns), which were approved on June, 2019(USFDA).

Advantages of Biosimilars

Biosimilars are nowadays gaining significant interest due to the advantages associated with it. They are as follows(Ragunadhan 2018)

  1. Reduction in cost:Biosimilar drugs are similar to original drugs, produce equivalent clinical outcomes to that of the original biologics but are less expensive (because their development is not associated with some of the costs borne by pharmaceutical companies in the development of reference agents).The reference drug monopoly is broken when multiple biosimilars are introduced in the market.
  2. Improved patient accessibility: As a number of biosimilar drugs are being launched in the market, and biosimilar drugs are found to reduce the healthcare cost by 40%, more patients can have access tosuch medical innovations at an early stage.
  3. Incentives for innovation:In the wake of expiring patents on reference drugs, innovative and patentable new biologic products may be necessary to maintain a large market share. This will encourage the pharmaceutical companies to invest more to foster innovation in biosimilar drugs.

Challenges of Biosimilars

Despite the benefits, there are few challenges and issues faced by biosimilar market which are as follows(Ragunadhan 2018, Stenger 2018)

Figure 1: Challenges of Biosimilars

Figure 1: Challenges of Biosimilars

  1. Education:Mass education is required in healthcare and pharmaceutical industry/patient and prescriber to enlighten them on the benefits of switching to biosimilars.
  2. Extrapolation issue:“Extrapolation is the process of granting a clinical indication to a medication without its own or new clinical safety and efficacy studies to support that indication”. Guidelines need to be developed to avoid confusion over whether the biosimilar can be used for the off-labelindications also.
  3. Interchangeability issues:Interchangeability issues ariseas the reference product can be substituted with biosimilar. Though guidelines have been published, there is uncertainty prevalent at the prescriber and pharmacist level.
  4. Rare diseases:Orphan drugs are developed for rare diseases. Though biosimilars are developed for the same, but there are many obstacles. It is a challenge to obtain sufficient  non-heterogeneous population for trials. Also, the cost for developing biosimilars to run batch-to-batch variability studiesis high.
  5. Approval process:Common challenges faced by biosimilar manufacturers in processing and packaging are the variability in critical quality attributes between the biosimilar drug and the reference drug which requires manufacturer to provide the FDA with adequate proof of clinical safety.
  6. Post-marketing reporting: As there is no clinical data available, post marketing surveillance is the only tool available to assess the efficacy and safety of biosimilars. However, as the post marketing surveillance process is a herculean task as felt by clinicians, many do not participate in the samedue to time and resource constraints.

Future of biosimilars

There will be a giant leap in biosimilar market in the coming decades(Ragunadhan 2018). As the reference products are nearing their expiry date, the biosimilars market is poised for added growth. Also, it is essential for the professional organizations to provide education and training about biosimilar drugs. This would spread awareness among consumers and healthcare professionals about opportunities and the challenges that these new agents are associated with.

Turacoz Healthcare Solutions, being an active provider of medical communication services, aims to inform people about the advantages and challenges of biosimilars. For any queries, write to us at [email protected]

References

Ragunadhan, M. (2018). Biosimilars: Benefits, Challenges and Futurehttps://blog.kolabtree.com/biosimilars-benefits-challenges-and-future/.
Stenger, M. (2018). “Opportunities, Issues, and Challenges for Biosimilars in Oncology.”  https://www.ascopost.com/issues/july-25-2018/opportunities-issues-and-challenges-for-biosimilars-in-oncology/.
USFDA “Biosimilar Product Information.”

INNOVATIONS IN PEER-REVIEW

Publication Writing, , , , , , , , ,

Peer Review is the process of evaluation of manuscripts submitted for scientific publication in journals/books, pre-clinical or clinical study reports, research progress reports etc., by experts or peers with similar competence as manuscript authors. It plays a pivotal role in scholarly publications with objective to ascertain quality, reliability and credibility of the work reported in the manuscripts and reports through qualitative scrutiny. This contributes to the acceptability of scientific work as authentic, rigorous and coherent for the intended purpose. Also, it widens networking opportunities within the scientific fraternity.

Types of Peer Review

  • Single blind review: This is the traditional and most common type of review in which the reviewer’s name is hidden from the author.
  • Double-blind review: In this kind of review, there is anonymity of both the author and the reviewer to each other.
  • Open review: The identity of the author and the reviewer are known to each other and there is more transparent communication during the review process.

Peer-review is a golden practice to improve the quality of publications but comes with its own set of disadvantages and shortcomings. Table 1 details the various featural pros and cons of different types of peer-review.

Table 1 Advantages and Disadvantages of Peer-Reviewing [1]

Ethics of Peer Review

As the reviewing experts are essentially from the same area or field of the study as of the authors of documents under review, some conflict of interests or differences in viewpoints may introduce bias that might come in the way of a fair peer review. For instance, a reviewer may not accept the manuscript/report under review if the author’s hypothesis is different from that of the reviewer. Indeed, many journals take this possibility into account and allow the authors submitting manuscripts to give the name(s) of reviewers to whom the manuscript should not be sent for review in addition to names of reviewers the authors would like to recommend. But then, peer review by reviewers recommended by the authors may also occasionally lead to undeservingly favored evaluation.

To avoid undesirable contentions, it is a prerogative for a peer-reviewer to adhere to ethical guidelines outlined by the Committee of Publication Ethics (COPE), which categorises the ethical responsibility of a peer-review into confidentiality of the data reviewed, objectivity of the review process and diligence towards their competency, following processes, policies and conduct [6].

A few ethical practices that should be incorporated in peer-reviewing are as follows:

  • Maintaining objectivity and diligence in assessing a document
  • Avoiding any favoritism or likewise, negative bias
  • Respecting confidentiality of the manuscript
  • Avoiding giving any personal or derogatory remarks
  • Refraining from disrespectful tone of criticism
  • Maintaining timeliness
  • Adhering to the rationales, norms, policies and specific scope of the journal
  • Promptly reporting any unethical duplication or data fabrication/design
  • Staying discrete from the author during the review process to avoid any unwanted confrontation

Essential Components of Peer-Reviewing

Studies conducted by scientists/experts/professional are rendered into a detailed article or manuscript, a draft of which is then sent to the journal editor. The article is sent by the journal editor to peer reviewers before publication. The reviewers then assess the manuscript and extend their comments focusing on the following aspects:

  • Adequacy of the background information (literature survey) justifying the necessity and purpose of the study reported
  • Appropriateness and adequacy of the materials and methods employed to generate the data
  • Compliance to national and international regulatory requirements [e.g. Good Laboratory/Manufacturing/Clinical Practices (GLP/GMP/GCP), Animal ethics, OECD/ICH/USFDA guidelines etc.]
  • Analysis of data using appropriate (statistical) methods
  • Proper interpretation and discussion of the data/results and the conclusions drawn.
  • Originality of the study
  • Presentation of the manuscript relying on legible and comprehendible language that is grammatically, technically and scientifically correct

Innovations in Peer Review

Any advancement or innovation in a process primarily requires recognition of the prevalent roadblocks. “Necessity is the mother of invention”, Plato’s misattributed proverb reflects the rationale of some compelling advancements that peer-reviewing attributes to the share of challenges it had faced.” Addressing some fundamental conundrums, there are many driven groups across the scientific fraternity who have offer valuable innovative answers.

  • Raising the satisfaction quotient of the author-reviewer-editor trilogy by ‘Volunpeers’

Lack of familiarity with the subject matter causes many reviewers to decline from reviewing. To overcome this challenge, the journal of Molecular biology enabled a Reviewer Recognition Platform, that facilitates reviewers, christened as ‘Volunpeers’ (to represent the rationale of this platform), to register for their area of expertise and receive manuscripts for reviewing according to their preference. The outcome of this platform was impressive! It proudly flaunted a high rate of involvement and satisfaction from both the reviewer and the editor and establishes a faith that peer reviewing indeed has not reached an intimidating stagnancy. Figure 1 indicates the promisingly positive impacts of Volunpeer-ing on various critical aspects [2].

Figure 1: Impact of Peer-Reviewing through the Reviewer Recognition Platform ‘Volunpeer’
  • Expediting the process of review and making it less cumbersome and time‑consuming

The dichotomy of time versus quality lead many to attempt to address long and tiresome process of reviewing. Recently, The Journal of Bone & Joint Surgery (JBJS) has initiated below mentioned tiny steps to upgrade their overall peer-review process [3].

  • Automated and weekly reminder emails to editors
  • Weekly reminder emails for editor queue statistics
  • Monthly emails delineating acceptance rates and transfer rates by editor
  • Shortened deadlines for peer-reviewing
  • Addition of manuscript Xtract in Editorial Manager that reduces manual entry for basic data like manuscript title, author-names, abstract and affiliations
  • Refining the review process by spotting errors and maintaining quality standards of review

The quality of any manuscript proportions directly to the errors established during review and editing process. A keen study conducted on ‘Improving the peer-review process and editorial quality by studying key errors escaping the review and editorial process in top scientific journals [4]. Figure 1 shows the common trend of errors encountered during review.

Figure 1: Proportion and types of errors during review/editing process [4]

The recognition of these error-patterns led to the application of a novel mistake index, independent of the journal’s impact factor. Mistake Index Total (MIT) represented the fraction of corrections published by total number of items published in a year and Mistake Index Paper (MIP) represented the fraction of corrections published by the total number of papers (categorised by articles) published in a year. These were then statistically analysed and applied on scientific journals of diverse disciplines to determine the type, rate of occurrence and severity of errors encountered. It is hence recommended that a detailed guideline based upon MIT and MIP be provided to reviewers, authors and editors, which can help them minimise error redundancy, reduce time-to-correction and reinforce quality of published manuscripts [4].

  • Ensuring recruitment of competent reviewers and providing visibility, value and appreciation for their efforts by R-index

On a more humane level, getting good reviewers and providing visibility, value and appreciation for their efforts stays a huge contributing factor to optimising the quality and efficiency of peer-review. Lack of recognition of time and valuable expertise of the reviewer often is a big dampener for review quality. A simple yet cutting-edge R-index (Reviewer index), has emerged as an essential metric to quantify and credit a scientist’s contribution as a reviewer, regardless of his/her stage of career. Based on the list of reviewers for any particular journal, number of papers reviewed, total number of words against the journal’s impact factor, and eventually fostered by the editor’s feedback on individual review, a score ranging from 0 to 1 is credited to the reviewers. Widely being accepted and implemented, this index is open doors to a wider academic productivity and increased transparency within the scientific community and works reciprocally towards maintaining and enhancing the quality of reviewing [5].

Conclusion

With a fair share of recognition as well as criticism that it comes with, peer-review is undoubtedly an essential component of the publication world. Although an overall positive impact and effectiveness of peer review mechanism to improve upon quality in biomedical journals has been observed in clinical trial and other comparative study publications, it is still difficult to ascertain its tangible impact, considering the aforesaid challenges [7]. Nevertheless, the brighter side shows that the existing peer-review paradigm is inevitably treading towards innovations; profoundly embedded into the process of scientific progress, its indispensable purpose gives reasons enough to boost its operations and we hope to witness more streamlining, transparency, efficiency, robustness and inventive tableaus in its modus operandi.

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances to help researchers stay abreast of important innovations in peer-review in the field of scientific publications. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Reference

  1. https://www.elsevier.com/en-in/reviewers/what-is-peer-review
  2. https://www.elsevier.com/connect/reviewers-update/innovation-in-peer-review-introducing-volunpeers
  3. https://www.csescienceeditor.org/article/new-innovations-in-peer-review/
  4. https://peerj.com/articles/1670/
  5. https://royalsocietypublishing.org/doi/full/10.1098/rsos.140540
  6. https://www.aje.com/arc/ethics-peer-review/
  7. https://www.bmj.com/content/349/bmj.g4145

Osteoporosis: Overview and Recent Advances in its Management

Awareness Day/Month, , , ,

Osteoporosis is a silent age-related skeletal disease characterized by loss of bone mineral density and microarchitectural deterioration leading to increased fragility and susceptibility to fractures. The most common sites of fracture are femoral neck, lumbar spine and distal forearm which more than often are debilitating and disabling if not intervened. Osteoporosis has affected more than 200 million people worldwide, with almost 8.9 million fractures reported annually across the globe. Close to 30% of postmenopausal women in America and Europe suffer from osteoporosis while India estimates not less than 50 million of its people in the plexus of this debilitating bone disease. The overall impact of osteoporosis is presented in Table 1.

Impact of osteoporosis
Table 1: Impact of osteoporosis

Assessed by a T score of less than -2.5 (World Health Organization definition in Figure 1) and a Z score significantly higher or lower than the average, osteoporosis may operationally be classified as the following 2 types:

Postmenopausal (type I): Linked to the fall in oestrogen levels, this type affects women between 50 and 70 years of age.

Senile (type II): Affects both men and women over the age of 70, but predominantly women.

Figure 1: Understanding the T-Score

Risk Factors for Osteoporosis

Using Fracture Risk Assessment Tool Model (FRAX) algorithms, several risk factors have been recognized that predispose men and women to osteoporosis. Smoking, alcohol consumption, high salt intake, immobilization, sedentary life, excessive weight loss reducing the BMI below 18.5 kg/m2, inadequate exposure to sun and socioeconomic factors have been shown to be significantly associated with its risk and incidence. The most common risk factors are shown in Figure 2, of which, modifiable factors like declining levels of sex hormones, anorexia nervosa, low calcium and vitamin D intake are attributed to faulty lifestyle. Public awareness campaigns have been spreading their annex to educate and motivate necessary changes towards preventing osteoporosis.

Figure 2: Common osteoporotic risk factors

RECENT ADVANCES IN OSTEOPOROSIS

Diagnosis

With one in three women and one in every five men over the age of 50 years worldwide are being estimated to face the risk of osteoporotic fractures in their lifetime [1], inclusion of diagnostic tests for bone health in their health check-up plans to help them get therapeutic or preventive measures in time becomes imperative.

  • Dual energy X-ray absorptiometry (DXA): Stands as the gold-standard for diagnosis of osteoporosis by determination of bone mineral density (BMD). However, the high capital cost of DXA created a need for alternative diagnostic tools.
  • Bindex®: Recently approved by United States Food and Drug Administration (USFDA) for osteoporosis diagnosis, it is a portable hand-held instrument that measures with 90% sensitivity and specificity, cortical bone thickness of the tibia. The algorithm calculates the density index, a parameter which estimates BMD at the hip as measured with DXA.
  • OsCare Sono: This is another inexpensive and small portable ultrasound-based instrument that measures bone strength from the forearm radial bone. It provided measurement results in a few minutes and they correlate well with bone cortical thickness, bone elasticity and BMD, including BMD of the deeper cortical layers. These attributes suggest a promising device that offers enhanced sensitivity to early osteoporotic changes.

Treatment

Currently, to accost the imbalance between bone resorption and build-up in osteoporosis, anti-resorptive and osteoanabolic agents crown the list and fall under the first and second line of therapy [9].

  • Bisphosphonates which bind to bone mineral and also inhibit bone osteoclast activity (resorption), are anti-resorptive agents which mainly increase the trabecular BMD and are one of the reliable and cost-effective first-line therapy options for both primary and secondary osteoporosis.  
  • Denosumab, a human monoclonal antibody, inhibits RANKL-induced bone resorption and increased cortical BMD.
  • Teriparatide is an N-terminal 34-amin acid long peptide of the parathyroid hormone which again acts on increasing lumbar BMD and contributes to prevention of vertebral and non-vertebral fractures.
  • Abaloparatide is again a peptide 34-amino acid long and belonging to the N terminal region of PTH-related protein. It has shown to be effective in increasing the lumbar spine- and proximal femoral BMD.
  • Romosozumab, an anti-sclerostin humanized monoclonal antibody, is shown to increase the lumbar spine- and proximal femoral BMD.

Table 2 gives a brief glance over the current mediation used to treat osteoporosis with their trade names.

Medications for osteoporosis
Table 2: Medications for osteoporosis

Apart from these current ones, there have been a surge in development of more efficacious drugs for osteoporosis management (Table 3).

Recent therapeutic agents for osteoporosis
Table 3: Recent therapeutic agents for osteoporosis

A minimally invasive targeted treatment in which local bone loss due to osteoporosis is restored by implanting a unique material that is resorbed and replaced by bone, is being offered as Ossure LOEP (local osteo-enhancement procedure) kit by AgNovos, USA. Also, during the last decade, vertebroplasty and kyphoplasty has also evolved as an effective surgical procedure in certain cases with subacute pain, oedema and focal joint tenderness.

THE KNOWLEDGE-PRACTICE GAP

Despite path-breaking diagnostic and therapeutic advances, there exists a lacuna in their application and compliance. Osteoporosis stays unfortunately and vastly, underdiagnosed and undertreated, and identifying these gaps in patient care becomes indispensable. A few of them are listed below:

  • Failure to follow screening guidelines for osteoporosis by physicians leading to erroneous assumptions and subsequent lack of appropriate treatment plan.
  • Inefficacy to treat patients sustaining fragility fracture with a timely intervention reducing the likelihood of preventing future fractures. One of the commonly observed reason is concerns around side effects of drugs like bisphosphonates, etc. which lead to reluctance from physicians in prescribing medicines and challenges in compliance by patients.
  • Underestimating the menace of osteoporosis especially by women who are more at risk but are unfortunately lesser concerned about its consequences; poor communication with physicians and non-compliance of screening and diagnostic recommendations puts patients at irreversibly damaging risks.
  • Inadequate follow-up and non-adherence by patients during the treatment regimen.
  • Insufficient funding and reimbursement of exorbitant diagnostic and therapy costs also remaining one of the main reasons why osteoporosis lies low on the priority list of patients.

PREVENTION

Rebuild. Refuel. Renew.

Although lifestyle choices, genetics and systemic diseases, and even certain medications pose as substantial risk factors, the good news is that osteoporosis is preventable.

  • Weight bearing and cardiovascular exercises: These not only work towards building muscles, but also strengthen bones, ligaments and tendons. In turn they improve agility, strength, balance and posture, considerably reducing the risks of fractures.
  • Dietary calcium and vitamin D3 intake: Falling on the fundamentals of skeletal science, calcium and vitamin D stay incontestable for bone health. A good balanced diet and adequate exposure to sun are always the safest choices to regulate calcium and vitamin D3 levels,
  • Supplements: calcium and vitamin D3 supplements are also often opted in times of nutritional inadequacy. Yet, concerns over prolonged supplementation causing serious adverse effects like hypercalcemia and hypercalciuria, have been cropping up lately. The U.S. Preventive Services Task Force (USPSTF) recently recommended “against daily supplementation with 400 IU or less of vitamin D3 and 1,000 mg or less of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women”.

“A thousand tiny steps can conquer the tallest tower”

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances in the field of clinical research, trials and regulatory affairs. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Here is Everything You Should Know About Cystic Fibrosis

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The month of May is commemorated as Cystic Fibrosis Awareness Month. It aims at raising awareness about cystic fibrosis (CF). Cystic fibrosis foundation (CFF) sponsors this month.

According to estimates, more than 70,000 people globally are affected by cystic fibrosis, but the prevalence of the condition varies globally. The US alone accounts for around 30,000 people living with cystic fibrosis. Around 1000 new cases of cystic fibrosis are diagnosed every year in the US. More than 75% of these cases are of children of age 2 or below. Asia and Africa are thought to be under-diagnosed for CF. Many nations don’t screen for CF in new-borns unlike the US, and the nation registries suffer from lack of data.

What is Cystic Fibrosis (CF)?

CF is a genetic disease that has an impact on lungs and digestive system of human body. Under the influence of this condition, the body produces thick and sticky mucus that can lead to blockage of lungs and obscure pancreas.

In individuals with CF, metamorphosis in the cystic fibrosis transmembrane conductance regulator (CFTR) gene makes the CFTR protein debilitated. When this protein doesn’t function properly, it is incapable of moving chloride- a salt component- to the surface of cell. Without the chloride to bring water to the surface of cell, the mucus in different organs turns thick and sticky.

The mucus blocks the airways and entrap germs such as bacteria, in the lungs, which lead to infections, soreness, respiratory issues and other complications. The people with CF need to be extra cautious and avoid contact with germs.

The thickening of mucus can also lead to infertility in males by clogging the vas deferens or the tube responsible for carrying sperms from testes to urethra.

Symptoms of CF:

Mentioned below are some prominent symptoms of cystic fibrosis:

  • Skin tasting very salty
  • Continual coughing
  • Running out of breath
  • Breathing roughly/heavily
  • Persistent lung infections inclusive of pneumonia or bronchitis
  • Problem with gaining weight despite of heavy diet
  • Infertility in males
  • Greasy and heavy stools
  • Troubles with bowel movements
  • Nasal polyps or slight fleshy growth in the nose

Due to the obstruction in lungs, infections like bronchitis and pneumonia can occur in the patient, leading to growth of pathogens. Blockage in pancreas contribute to malnutrition and poor growth. The risk of developing osteoporosis and diabetes is also associated with it.

Causes of Cystic Fibrosis:

Since CF is a genetic disease, to be affected by it one is required to inherit the mutated gene from both of their parents. The mutated genes are the carriers of codes that produce protein controlling the flow of salt and water on the surface of organs, inclusive of pancreas and lungs.

People suffering from CF struggle with the balance of salt and this leads to more salt and water on the surface of cells and formation of very thick mucus.

Individuals with a single copy of the mutated gene are known as carriers. They do not fall prey to the condition or symptoms of CF. For someone to be affected by CF, both their parents must be the carriers.

If two people are carriers and have a child together, there are:

  • 25% chances that the kid will have CF
  • 50% chances that the kid will be a carrier, but won’t suffer from CF
  • 25% chances that the kid will neither be the carrier and nor suffer from CF

Treatment for CF:

At present, CF is not curable. Certain treatments work on controlling the symptoms and improving quality of life for CF patients. Depending on the kind and intensity of symptoms, the treatments are personalized.

Clearing airway

It is very important for CF patients to reduce the level of mucus in their lungs in order to breathe easily and avoid any lung infections.

Airway Clearance Techniques (ACT) helps individuals with CF to soften their mucus and get rid of it from their lungs. Inhalable medications are effective in reaching the airways and are usually used. The medication can be given through aerosol or through inhalers. These medications help in thinning mucus, killing bacteria and setting off mucus to enhance airway clearance.

Antibiotics act as an essential part of routine care. These can be consumed orally, through injecting and inhalation. Some other medications like azithromycin and ibuprofen are said to protect and enhance lung function and now made a part of standard therapy for CF patients.

CF patients can lower the risk of developing lung infections by taking the below mentioned steps:

  • Washing hands often
  • Avoid smoking
  • Avoid futile contact with people suffering from cold or other contagious diseases
  • Getting a flu injection every year

Other styles of treatment:

Other than the airway clearance technique, there are other types of treatment too.

Implanted devices:

These allow long-term contact with the bloodstream for constant supervision of drugs. These are capable of making the management of CF more powerful and less invasive.

CFTR Modulators:

CFTR (CF Transmembrane Conductance Regulator) modulators are the recent medications developed to focus on the defective CF-causing gene. They help in easing the flow of salt and fluids on the expanse of lungs and weed out the heavy mucus that CF patients generally form in their lungs.

At present, two CFTR modulator brands are certified by FDA (Food and Drug Administration), namely Orkambi and Kalydeco. They’re recommended for children suffering from 10 distinct mutations of the CF-causing gene. Kalydeco might be recommended for kids of age 2 years or more, whereas Orkambi is for kids aged 6.

Remedial measures based on Nutrition:

CF affects the digestive system adversely and the patient suffers from poor nutrient absorption. It is recommended that CF patients should consult their doctor regarding their diet. A nutritionist would assist them in having a control of digestive symptoms.

To balance the digestion of nutrients, a variety of additional supplements like pancreatic enzyme supplements, vitamins or salt might be required along with a specific kind of diet.

CF is responsible flawed growth. To ensure proper development and growth in affected children, a diet rich in calorie and fat, is very essential. It also helps adults in maintaining optimum health. Good nutrition is very crucial for CF patients so that they can be safeguarded against high risk of lung infection.

Cystic fibrosis cannot be cured as of now but with proper care, treatment and diet, the symptoms of it can be controlled. The average life expectancy of CF patients is early 40s. The life expectancy may vary based on the intensity of the symptoms, age of diagnosis and the kind of mutation in gene.

The life expectancy of CF patients has increased significantly in last few years, being around 47 years. There are many patients living well in their 50s or 60s.

Turacoz healthcare solutions, a medical communications firm, believes that appropriate treatment and caution is the key to control currently incurable diseases like cystic fibrosis. Turacoz provides cost-effective medical writing services like regulatory writing, publication writing, advisory board meetings, etc. To know more about Turacoz and to avail the services, drop a mail at [email protected]

Talc, a cosmetic ingredient: Safety issues

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Most of us have possibly used it or sprinkled on our skin at some point in our life, ‘Talc’ which is a processed from of soft mineral compound of magnesium silicate and is called talcum powder or just talc in general terms. The natural smoothness and adsorbency of talc have been utilized since millennia and its use dates back to the Egyptian time. Some of the major brands utilizing talc’s adsorbent properties are Nivea, Pond’s, Cinthol and Johnson & Johnson. Ideally, cosmetic grade talc should not contain asbestos but recent lawsuits against Johnson & Johnson have claimed its presence in the marketed cosmetic products.

Non-clinical Findings

In 1993, the National Toxicology Program (NTP) in their report stated that there were some evidence of carcinogenic activity in male F344/rats, clear evidence of carcinogenic activity in female F344/N rats, and no evidence of carcinogenic activity in male or female B6C3F1 mice exposed to aerosols of 6 or 18 mg/m3 non-asbestiform cosmetic grade talc in a lifetime study. In 2010, the International Agency for Research on Cancer (IARC) Working Group reported that there is a limited carcinogenicity evidence for talc (not containing asbestos/asbestiform fibres) in experimental animals.

Clinical Safety Alerts

Talc has been safely used and is well tolerated since many years and recent scientific reviews on available data have supported this position lately. However, the first alert associated with genital was reported by identification of talc particles in ovarian cancers which came in 1971.

This finding was strongly contested by Dr G.Y. Hildick-Smith, Johnson & Johnson’s medical director. A subsequent publication in the Lancet warned that “The potentially harmful effects of talc in the ovary should not be ignored”. This warning was confirmed in a 1992 Obstetrics & Gynaecology publication, reporting that a woman’s frequent talc uses on her genitals increased her risk of ovarian cancer by threefold. The talc in question was simple brand or generic ‘baby powder’.

Unexpectedly, the mortality of ovarian cancer in women over 65 years of age has escalated sharply, especially in black women who have a higher rate of talc use as compared to other races. Almost 16,000 women in the United States die from ovarian cancer yearly, by some estimates, one out of five women regularly applies talc to her genitals either via direct application, or from tampons, sanitary pads and diaphragms that have been dusted with talc.

Conclusion

IARC reports perineal use of talc-based body powder to be possibly carcinogenic (Group 2B) in humans, and that inhaled talc (without asbestos or asbestiform fibres) is not classifiable as to its carcinogenicity (Group 3). Additionally, the US Cosmetic Ingredient Review Expert Panel published a safety assessment of talc as used in cosmetics. It concluded that talc is safe for use in cosmetics in the present practices of use. Johnson & Johnson faced continued concerns on about the threat posed by lawsuits over the safety of the company’s signature baby powder. The company has always denied the allegations and maintained a swift stance on the safety of talc.

At Turacoz Healthcare services, we provide end to end toxicology and regulatory assistance to meet the high standards set by the regulators worldwide. We provide exhaustive toxicology/safety literature search from pre-clinical to post-marketing stage. We provide consultation at various stages of product lifecycle in order support the ingredient compliance with the guidelines of respective regulatory bodies.

Medical Diagnostics: An Update

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Diagnostics play a very important role in our everyday life, be it for a disease, condition or identification of a risk factor. Various diagnostic advancements viz. novel techniques, devices, pathology and laboratory services, etc. are introduced regularly in the market by companies across the globe to help improve the lives of people and ensure quality‑care for patients.

The first quarter of 2019 featured some important updates on medical diagnostic and innovations and some are shared below:

  • Paper-based LAMP Diagnostics for Detecting Malaria

According to the World Malaria Report 2018, 219 million people were affected by malaria in 2017. Diagnosing the same is difficult in rural areas and in developing countries. Keeping the disease burden and non-accessibility in mind, scientists have developed a low-cost portable device which accurately and efficiently detects malaria. The technique uses a paper infused with loop-mediated isothermal amplification, LAMP, which involves printing with hydrophobic wax using a commercial printer and then heating the paper on a hot plate to bind the wax with the paper [2]. The paper attached to a lateral flow device helps in containing the blood sample (DNA) for the detection of malaria. This device uses amplification and detection techniques which help in identifying Plasmodium falciparum, the malarial parasite. This device was used to detect malaria in 67 school children from 2 different schools in Uganda. The results were also compared to the gold standard test in malaria, PCR. The new device showed promising results by identifying 98% of the malaria cases and is now undergoing further research for proper implementation.

  • Objective Diagnosis for PTSD

Posttraumatic stress disorder is associated with functional impairment involving delayed-speech and substance abuse. Diagnosis of PTSD involves long-term counseling sessions which often tend to get biased owing to the subjective nature of the entire process. Also, patients are often reluctant and unwilling to visit the clinician in-order to avoid confrontation. Diagnostic biological markers, though available for PTSD related factors, are not cost-effective. Further, PTSD has a high disease burden which limits the success of these markers.

A software known as the random forest was developed by researchers which assesses speech patterns for variations in speech, lifeless, metallic tone of the speech along with animated speech using AI. It provided 89% accurate results in the tested participants. The software was fed with data on various speech patterns which it uses as training data to grasp better and provide suitable results. With the use of this preliminary information, clinicians can use naturally collected data for diagnosis of PTSD. This technique, however, is still under research and hopes to aid in the diagnosis of PTSD.

  • Blood Test for Detecting Breast Cancer Relapse

The second most common type of cancer-causing death in women is breast cancer. It can be detected using various methods such as mammography, ultrasound, etc. Although the survival rate has improved in comparison to earlier times, relapse is still a very important concern. Approximately 30% of the patients suffer through a relapse within 5 years. Natera, a genetic testing company has developed a blood test by the name of Signatera, which detects the mutant DNA released by the cancerous cells. The technique, known as Molecular Residual Disease (MRD) Assessment is used for early detection of breast cancer, enabling patients to take proper precautionary measures. This technique was found successful in 89% of relapse cases. The detection, however, has to be clinically confirmed for a confirmed diagnosis. The researchers aim to test this in a large number of the sample population in order to bring this into mainstream diagnostics.

  • New Diagnostic Manufacturing Facility Launches in India

Co-Diagnostics Inc. and Synbiotics Pvt Ltd, together in partnership have launched a diagnostic manufacturing facility in India. It is said to be a one-of-a-kind facility providing state of the art facilities in the world of diagnostics. The owners are known for developing facilities which have global approvals from the leading regulatory bodies (US Food and Drug Administration, World Health Organisation-Good Manufacturing Practices). This facility is not only ready to start operations in India but has plans underway for further expansion. Asence Inc, a US company which specializes in providing pharmaceutical products to various markets, would be managing the commercial operations for the facility.

  • VITROS® XT Chemistry Product Slides (FDA approved)

One factor that delays the diagnosis of various diseases is the delay in lab test results. These diagnostic tests are either time taking or are too many done at one time, which in turn delays the results. Ortho Clinical Diagnostics have come up with a new VITROS® XT MicroSlide which can run two tests simultaneously, thus reducing the time required to conduct these tests along with less usage of the products. Ortho’s VITROS XT MicroSlides, which are available for use on Ortho’s VITROS® XT 7600 Integrated System, provide high-quality results and are used for paired tests such as, triglycerides and cholesterol; urea and creatinine; and glucose and calcium. The miniature testing area in the slide is highly efficient and requires less amount of sample for providing results. With this FDA approved technique (approval received in October 2018), multiple tests can be done together, thus saving time and infrastructure.

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances in the field of clinical research, trials and regulatory affairs. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Regulatory Troubles Clamping Down on OTC and Other Healthcare Products

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The regulatory authorities have been on fire lately. They are vigilantly sniffing any suspicious and harmful substance in healthcare and OTC (Over the Counter) products. They are working towards the standardization of products which has added to the woes of some famous names as well.

Everything going wrong with Johnson & Johnson (J&J)

The most popular baby product brand Johnson & Johnson lands into trouble again. This time The Rajasthan Drugs Control Organization has indicated that two batches of company’s “No More Tears Baby Shampoo” had ‘pernicious elements’, to which J&J, not long ago, has classified as carcinogen formaldehyde and has denied the test results.

Earlier, the baby powder of the company was also in news and that was because of no good reasons. The baby powder of the company was suspected of having asbestos (a cancer-causing element).

Only a month ago, the US healthcare colossal got clean chit from the government and proceeded again with the production of their baby powder at their plants in India. Now they are encountering troubles with the baby shampoo and are on the radar of domestic drug regulatory authorities.

This is a serious threat to the image of J&J and their well-established market in a place like India. Two batches of J&J’s baby shampoo failed the quality test, as per the reports by Indian Express. The samples of the batches BB58204 and BB58177, to be expired in September 2021, were tested positive for harmful and objectionable ingredients.

These samples containing one lakh bottles of “No More Tears Shampoo” were manufactured at Baddi, Himachal Pradesh. Rajasthan government has asked to withdraw these adulterated batches and has demanded the regulatory authorities of other states to follow the litigation.

The regulators found the presence of formaldehyde in the samples of shampoo. Formaldehyde has been declared as a probable carcinogen substance by the US Environmental Protection Agency. The studies conducted in past have shown a link between formaldehyde and a greater risk of leukemia.

Rajasthan drugs auditors relayed a notice to drug control officers to withdraw the available stock, so that the stocks of these drugs are not used by anyone and the consumers are safeguarded. Further, it was also notified to take appropriate actions in accordance with provisions of the Drugs and Cosmetics (D&C) Act 1940 and rules made afterwards.

J&J has though, denied any such allegations. It has claimed that neither did the government revealed the method of testing used and nor did it state the details and quantitative findings. A J&J spokesperson said that the samples were drawn at the start of this year and the company has extended full support during the whole process.

J&J stated that they had been inveterate to the Indian authorities that they have forbidden adding formaldehyde to their shampoos and nor does they use any such element in their shampoos that can release formaldehyde with time. J&J also claimed that their products are safe to consume and are manufactured in accordance with the standards of D&C Act and rules.

J&J has declared that they extend their full support to Indian regulatory authorities and act according to their regulatory requirements. The US healthcare giant has also applied for re-testing of their samples at Central Drugs Laboratory.

Adding to J&J’s anguish, Central Drugs Standard Control Organization (CDSCO) has planned to investigate the matter more scrupulously.

Reviewing of dispensations to Dettol, Savlon and other antiseptics, by the panel

Dettol, Savlon and other products of similar nature are liberated from getting a sale permit, as per Drugs and Cosmetics Rules, 1945. An expert panel now has been set up by Drug Controller General of India (DCGI), which will be deciding whether OTC healthcare products will be proceeding further with an exemption under disinfectants and antiseptics.

According to clause 12, schedule K of the Drugs and Cosmetics Rules 1945, “substances intended to be used for annihilation of vermin or insects, which produce disease in human beings or animals, like insecticides and disinfectants, can be stocked, exhibited and sold without a license.”

Currently products like Savlon, Dettol, etc. fall under the clause 12, schedule K. This ensures that they do not need any sales license. This matter, however, has now been consigned to a sub-committee for further investigation. It shall also be reviewed whether these products can be kept under the category of OTC products or ‘no-prescription’ products.

Dettol is a popular first-aid product, used as a disinfectant and it contains additives like terpineol, chloroxylenol and absolute alcohol. The reason for this action is to ensure the safety measure of these products. Such products, being a crucial part of infection control strategies in healthcare regimen, are required to be monitored closely. It is also because these products play a major role in antimicrobial resistance, so their manufacturing and usage becomes even more crucial.

The US Food and Drug Administration (FDA) also took a similar action in the year 2017, when it shut down the use of 24 elements in OTC antiseptic products like handwashes and surgical hand scrubs.

Things not going smooth for Claire

No one can deny the fact that cosmetics have been deeply rooted into the daily routine of our lives and hardly any woman walks out without wearing makeup or using any sort of cosmetic products. The widespread use of cosmetic products has made it even more important to screen them carefully in order to avoid any possible harmful effects.

With a wide range of cosmetic brands available, more vigilance is required. Recently, a popular cosmetic brand, named Claire, has been under the radar of FDA.

FDA called on Congress to alter the rules for cosmetic safety as it broadcasted an alert for consumers against 3 of the products sold by Claire Stores Inc. This was because these products were tested positive for asbestos- a product that causes cancer. The presence of any carcinogen element in any product is not acceptable.

The 3 products against which the warning was issued are:

  • Claire’s eye shadow palette
  • Contour Palette
  • Compact Powder

The retailer, who just escaped from the jaws of bankruptcy, stated that there is no proof that any of the product sold by Claire is risky. Though, as a measure of precaution, the retailer removed the stated 3 products from the store and any other such product that was talc-based.

Claire, however, has challenged the test results shown by FDA and says that it has misunderstood fibers present in the products as asbestos.

FDA has been under huge pressure to screen for any asbestos presence in the products, especially after the J&J case, where asbestos was found in their baby talcum powder. The reports from the Reuters stated that J&J was aware that their talc, in raw form, contains asbestos, from 1970s to early 2000s.

No favor to flavor: FDA plans on imposing restrictions on Flavored E-cigarettes sales to teens

The commissioner of FDA has decided to put a restriction on the sale of flavored e-cigarettes in order to minimize the rate of teenage vaping.

Vaping is practice of inhaling and exhaling vapors formed by an e-cigarette or electronic cigarette or any related device. The issue associated with this is that youngsters, especially teens might take up vaping as an alternative less harmful than smoking.

The agency has suggested in a proposal that the stores cloister flavored electronic cigarettes to areas prohibited to anyone falling below the age of 18. All retailers inclusive of departmental stores and gas stations will have to mandate the age verification of the customers.

There are enough proofs to show that youngsters are drawn towards flavored e-cigarettes and the minors have access to these from physical and online stores, despite of the fact that there are federal restrictions imposed on sale of such items to anyone below 18.

The increasing rates of teenage vaping is a serious concern over the past few years. Around 3.6 million middle and high school kids confirmed that they were involved in vaping, as per a study conducted by Centers for Disease Control and Prevention.

Previously, FDA repressed teenage vaping by issuing a threat warning to put a ban on maximum flavored e-cigarettes and asked retailers to stop selling them to minors.

The recent proposal states that the sellers need to filter the sale of such items according to the area. If any store caters to customers of all age group, then they might be required to have a separate space/room for such products, so that minors don’t have direct access to it.

Though many retailers aren’t happy with this and have even threated to fight against these stipulations in court. Conservative groups and vaping trade associations also seem to be in no mood for support and have stated that the efforts made by the agency to regulate e-cigarette industry corresponds to government overdo.

The new stipulations are not applicable on menthol, tobacco or mint flavors as the FDA wishes to keep them available for adults who are trying to quit volatile smoking with the help of e-cigarettes.

Meanwhile FDA plans to monitor the use of mint or menthol flavored e-cigarettes by the youth and upon finding excessive use by the youngsters, it would reconsider the exoneration of these products. This step is not going to be in favor of Juul labs, the vaping colossal. Juul has already shifted the sales of its products online, other than the mint and menthol flavored ones.

The proposal made is still in the draft phase and is required to abide by a 30-day comment period prior to its finalization. This regulatory approach is bit off-beat as it is neither an autonomous guideline nor a new rule. FDA has mentioned that if the e-cigarette manufacturers sell their products in contravention of the solicitation, then their products can be lifted off the market and asked to apply for approval from the agency. FDA can carry out this action under its discretionary enforcement authority.

With time, more emphasis is being given to the safety and efficacy of healthcare and cosmetic products. Proper measures should be taken to avoid the presence of any harmful substances in these products and ensure the safe usage. The safety and health of consumers is becoming a primary concern.

The regulatory authorities across the globe are working hard towards maintaining the standard of the manufacturing of these products by implementing stricter measures of screening and making amendments to the safety rules.

With the changing regulatory requirements and parameters, even the big giants need to buckle up and prepare for the best and ensure quality products from their end to stay out of any likely troubles. How things unfold in the future, would be a sight to see.

Turacoz Healthcare Solutions, being a medical communication firm, realizes the significance of drug safety and efficacy and believes that the manufacturing standards of the drugs and cosmetic products should be at par with the regulatory standards and rules. Consumer safety is a priority and the regulatory authorities are working on the same by fastening the grip on major healthcare and OTC product players, to ensure that the products are of standard quality and their consumption is safe.

Turacoz offers quality and cost-effective medical writing services. To know more about our services, write to us at [email protected]

New Drug and Clinical Trial Rules 2019, INDIA What they bring to the table!

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Effective from March 19, 2019, The New Drug and Clinical Trial Rules released by the Ministry of Health and Family Welfare have met with mixed reviews by the industry. These rules which apply to Investigational new drugs for humans, clinical trials, bioequivalence and bioavailability studies, except the chapter on ethics, were much awaited by the healthcare industry in order to bring a change in the clinical research sector in India.

These new rules have brought quite a few changes to the previously published Drugs and Cosmetics Rules, 1945, the name itself, being the first.

Reduced Timelines

The drug approval regulatory body- the Central Drugs Standard Control Organisation (CDSCO) will have 30 days to respond to a clinical trial in India and 90 days for global trials with India as one of the site. Failing to respond within these timelines, the trials will be deemed as approved. Earlier, these approval timelines were a major challenge as these could take anywhere from six months to one year.

This, however, would add on to the pressure for CDSCO to approve trials within the stipulated timeline.

Hello phase IV

These rules state that the drugs and indications approved by the regulatory authorities like Food and Drug Administration, European Medicines Agency, etc, would not require a phase III to test the efficacy and safety in India and can directly skip these to a phase IV, to be promoted to the Indian population.

This rule would also apply to Orphan drugs which are used for treatment of rare diseases affecting less than five lakh Indians. With this rule, the accessibility of drugs for the Indian population is believed to increase and will help them in getting better treatment options. Whether these drugs be effective for the Indian population who differ from their counterparts, is still an unanswered question.

Free Post-trial drug access

Trial participants enrolled in clinical trials did not have access to the drugs under study until they were marketed after completing the necessary steps involved. This, however, has been revised in the new rules. Participants will have access to the trial drugs post-trial if and only if there is no other alternative available. Also, the trial participants would have to submit a written waiver to the sponsor, relieving them of the responsibility of any post-trial complications caused by the drug under study. 

Clinical Trial Approval Validity

The approved clinical trials would have a validity of two years which is extendable by one year. This is aimed at fast-tracking the trials and in turn, would help patients to get faster access to drugs.

Welcoming equality

The New Drug and Clinical Trial Rules would now apply to bioequivalence and bioavailability studies and consider them at par with clinical trials. This would help in understanding these studies in terms of their conduct, analysis, and reporting. It has also been mentioned to acknowledge the centers conducting these studies.

Compensatory vows

It has been stated that the compensation for death or permanent disability of the trial participants would be decided by the Drug Controller General of India. Also, free compensation for trial-related disability or injury would be extended until the injury subsides or is no longer related to the trial or drug under study. There is, however, a catch in this clause. This extended compensation would be provided under the guidance of the trial investigator. So, if the investigator feels that the injury is not trial related or is no longer associated with the trial, his opinion would be deemed final. This does put the trial participant at a bit of disadvantage.

These rules aim to promote clinical trials and studies in India, which has a very high disease burden, yet only 1.2% of Global clinical trials are conducted here. Hopefully, these rules would help India be taken seriously as a country which supports ethical Clinical trials and studies, providing opportunities for various Global leaders to see India in a different light.

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