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Biosimilars: Advantages & Challenges

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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

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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

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.

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]

Moving to Virtual Clinical Trials

Clinical Trials, , , , ,

 

In the clinical trials industry, 80% of trials do not meet enrolment timelines, leading to a loss of $8 million per day. Delayed enrolment not only impacts trial timelines, but more trials are being cancelled because of it, preventing investigators from determining the safety and efficacy of what could be promising new therapies for patients who need them the most.  This loss can be dealt through incorporation of virtual clinical trials. Unlike traditional site based clinical trials, virtual clinical trials do not require multiple study sites. Though some research space will be required for management of a virtual clinical trial, it can generally be organized from a single facility. Also, patients need not be in proximity to sites, and the data collection requirements fit more easily into their everyday routines, improving compliance and patient engagement. Greenlight insights reported that virtual industry will reach $7.2 billion by the end of 2017, and is expected to touch $74.8 billion by 2021.

Virtual clinical trial is a new method of collecting safety and efficacy data from trial participants, from scratch of the study through execution to follow-up. The participant does not have to travel to the trial site and can make use of simple mobile applications to report general information and adverse events. Body temperature and other vital signs are send directly to the electronic data capture records via wearable sensors.

What are the benefits of virtual clinical trials?

The advantages of virtual clinical trials compared to the traditional trials are mentioned below.


Figure 1: Benefits of virtual clinical trials
  1. Maximizes patient availability and enrolment: The patient recruitment phase is longest in clinical trials and almost 80% of the study fails to reach the initial target.
  2. Overcome of mobility issues: As the patient is not required to travel to the trial site or doctor’s office, it is convenient for elderly participants residing in remote area.
  3. Keep subjects engaged with the study: Almost 40% of the phase III clinical trials subjects drop out from the study due to many factors such as inconvenience in travelling, complexity of trial design and data collection procedure. However, virtual clinical trials does not require patient to travel to clinical study sites. Also, the data collection procedure is automated which increases the patient engagement and reduces the dropout rates.
  4. Better data collection: Data collection is made easy by electronic data capture records hence; the timelines can be achieved at a faster rate.
  5. Benefits to research team: With notifications, scheduling and reporting functions, researchers are freed from performing tedious administrative duties.
  6. Reduce risk in drug development process: Real-time data analysis and data cleaning can be carried out simultaneously. Based on the real time clinical trial data, decisions to terminate drugs development can be made faster.
  7. Cost effectiveness: The reduced number of sites involved in the study leads to reduction of the cost. While trial staff will likely still be based at a single site or a reduced number of sites in multi-site trials, the operating costs will be significantly lower.

Key challenges of virtual clinical trials

  1. Sometimes
    technology may fail:     When everything
    relies on technology, challenge arises if it won’t operate optimally.
  2. Data accuracy
    problems:     As the patients will not face the
    doctor directly, doubts exist whether ideal standard treatment care is provided
    for the patient.
  3. Conservative in
    approach:     Corporate conservatism is another
    major challenge as it is difficult for the sponsors to move on from traditional
    method and trust the data generated from virtual clinical trials.
  4. Challenges in
    device selection:      There are concerns that the device model, the position at which the
    trial participants wear it and other factors could introduce variability into
    the trial results.

Pioneers in virtual clinical trials

REMOTE (Research on Electronic Monitoring of Overactive Bladder Treatment Experience) trial by Pfizer in 2011 was the first virtual clinical trial. Though, the trial faced many challenges, it was the first trial to use web and smartphone based patient recruitment. Also, the patients were not required to visit the study site.

Turacoz Healthcare Solutions aims to provide information regarding the latest trend in clinical trial industry. Turacoz is a medical communications company, which offers services to healthcare professionals in clinical research, regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

To know more about us and our services, write to us at [email protected]

Financial Disclosures in Medical Publishing

Medical Publishing, , , , ,

Introduction

Financial disclosures enable the readers to evaluate the potential conflict of interest (COI) which probably builds the trust of transparency in the medical publishing’s.

Importance

The financial disclosures are made available to the readers either in the published article or by posting the submitted financial disclosure forms online along with the published article. It allows the readers to evaluate the author disclosure with COI and analyze the financial aspect of the published material. Furthermore, it allows one to interpret the information provided in the article accordingly in the gleam of all those disclosures.

Consequences

  • Many scientific journals and funding agencies have adopted and regularized it for the authors to disclose all finance related interests to improve the uprightness of science and manage all COIs. The complete disclosure removes the inkling of hiding some relevant information regarding the object.
  • It allows the reader to draft their own opinion on whether a COI exists and what significant association it has with the study.
  • Readers and editors easily recognize that several nonfinancial forms of bias, may it be executive, cognitive, competition at academic level, or discriminatory based on personal confront can affect a study or the reviews.

Over the past few decades, only the financial disclosure has emerged as an attainable goal among the above stated, but the process has not been perfected either in concept or practice.

The financial disclosure remains a debatable topic in field of medicine with some finding the requested reporting burdensome and others still unsatisfied that declaration is pellucid, at its best.

Turacoz Healthcare Solutions, a medical communication company providing medical writing services, understands the significance of financial disclosures in medical publishing.

Turacoz provides services like scientific writing, publication writing, regulatory writing, clinical trial writing support, pharmacovigilance support, etc.

To know more about the services and to seek help, you can write us at [email protected]

New Drugs For HIV: Making An Impact On HIV Treatment

Drugs and Disease, , , , , , , ,

The global statistics for HIV/AIDS 2017 have revealed that around 37 million people across the globe were affected by HIV, out of which 1.8 million were children. 1.8 million new cases of HIV were registered in 2017, making it about 5,000 new cases per day.

Around 75% of the total people affected by HIV were aware of their condition, whereas the rest 25% were yet to be examined. HIV screening is very important and crucial for its prevention and treatment. 21.7 million HIV positive people, globally, were having the access to antiretroviral therapy (ART).

Though the deaths due to AIDS have been reduced by 51 %, globally, there is still a lot to be done for this condition. Till date, we have no cure for HIV. There are various advancements in the drugs for HIV treatment, but there hasn’t anything been invented yet that can cure HIV forever. In such a case, every new drug invented and approved is a ray of hope for many HIV patients worldwide.

New drugs approval for HIV:

Recently, the US Food and Drug Administration gave its approval to two new drugs developed for treating HIV-1, the most common form of the virus.

Over the decades, this disease has been researched upon and understood by various scientists and efforts have been made to find treatment for the same. This approval signifies the potential and improvement in the treatment of the ailment and states that the options for treating the condition have now increased.

Known drug manufacturer, Merck, announced that FDA have approved the two new antiretroviral drugs- Delstrigo & Pifeltro.

These oral medications are targeted toward those adult HIV patients who have not been exposed to antiretroviral treatments before. These medications aren’t meant for the patients who have been previously receiving the antiretroviral treatments.

The approval for these drugs was granted posted the successful phase 3 clinical trial of these 2 drugs. The trial involved 700 participants for each drug. Both the medicines had same side effect of reducing the cholesterol levels.

People with HIV are now living longer life and with the recent statistics it can be inferred that very soon HIV positive people will live longer than 50 years. In such situation they are most likely to be exposed to issues like high cholesterol. So, in such conditions, the side effects of these drugs can prove beneficial as they lower down the cholesterol.

No single drug is effective for HIV patients. So, people who are looking forward to these drugs must consult their doctor beforehand to figure out the most suited treatment for them.

Choosing a certain drug or treatment regimen depends highly on various factors such as other medical issues faced by the patient, possible side effects and drug interactions. As more and more drug being available for the treatment, customized treatments can be generated keeping in mind patient’s condition.

The complexity of HIV/AIDS is still highly misunderstood by people in general and a lot is yet to be done in treatment of HIV.

Turacoz Healthcare Solutions hopes that more and even better drugs will be manufactured in near future which will make a positive impact on the treatment of HIV/AIDS and hopes that the new drugs manufactured will help in treating HIV and benefit HIV positive people.

Being a medical communication company, Turacoz wishes for HIV positive people to live a long and healthy life. Turacoz offers medical writing services like clinical trial support, pharmacovigilance support, regulatory writing, etc. and is updated on the recent advancements in the treatment of various diseases.

To know more, write us at [email protected]

Myths about HIV/AIDS: Busted

Awareness Day/Month, , , , ,

Ever since HIV/AIDS is discovered, there have been lots of rumors surrounding it. This article aims at busting those myths and presenting the fact.

HIV-Human Immunodeficiency Virus attacks the immune system of human body and makes a person weaker and increases his disability to fight against diseases. This is caused by having unprotected sex with a HIV positive person and using shared needles/syringes for injecting drugs.

There are various myths about HIV. Let’s have a look at them and then get aware of the reality:

  • You can get HIV by being around a HIV positive individual: This is the most popular rumor surrounding this situation, that you can get affected by HIV by staying around a person who suffers from this disease.

Fact: You cannot get affected by HIV by shaking hands, touching, hugging, kissing or sitting together with a HIV positive person. The HIV virus transfers to your body through vaginal fluids, semen and blood of a HIV positive person.

  • HIV is caused by mosquito and insect bites: Another popular myth which says that if a mosquito bites a HIV positive person and bites you too, then you can also get HIV.

Fact: One cannot get HIV from any mosquito or insect bites. Mosquitoes never inject blood in your body, not does any other insect.

  • You cannot live long, if diagnosed with HIV: A common misconception is that if you have HIV than your life is cut-short or say is over. You will die soon.

Fact: HIV does not mean that your life is over. When it came into knowledge, there were any deaths due to it because there was nothing that we knew about this disease. But today, a lot is known about it. Though there is no fix cure for this, but still, there are certain treatments and therapies that help control the damage HIV does to your body. If one follows proper therapy and takes daily doses, one can live a normal, healthy and long life.

  • Having sex with a HIV positive person will get you HIV: Another myth, that says, if you become physically intimate with a person who is HIV positive, you can also get affected by the virus.

Fact: It is very important to understand that how HIV spreads, what are the risk factors and the preventative measures. By using quality condoms, you can lower down the risk of transmission of this virus. Practicing safe sex is the key to stay away from getting infected with this virus.

  • A woman affected by HIV will pass it on to her baby: This myth states that a HIV positive woman will pass on this virus to her baby during pregnancy and the baby with be HIV positive too.

Fact: This can only be possible in the case where no proper measures are taken to prevent the baby from the virus. A HIV positive woman can prevent her baby from getting infected by taking proper treatments at the right time. There are some treatments available that ensure safer deliver of child and keep him/her virus-free.

  • There is no need for condom if you use HIV Prevention Pill: A myth that says, one does not need to use condoms if he/she is taking a PrEP.

Fact: PrEP (HIV pre-exposure prophylaxis) is a technique through which the use of a regular antiretroviral pills can lower down the risk of getting infected by HIV by as much as 92%. But this does not state that the condoms should not be used at all. It is always good to stay on the safer side.

  • One can stop using condoms if he has an undetectable virus: A myth that says if you have suppressed your viruses to an undetectable level, you should quit using condoms.

Fact: It is true to a certain extent that a person who has suppressed his viruses completely such that they become undetectable, is less likely to transmit the virus. But this doesn’t ensure that there aren’t any factors that can increase or reduce the risk individually.

  • We are on the verge of curing HIV/AIDS: Another false claim that the cure for HIV is about to be discovered.

Fact: There are numerous researches going on and a lot has been understood on this disease. Advances are being made but we are not yet close to disclosing the cure for it. Till date, this disease has no permanent cure and only certain drugs are available which can help control the damage.

  • Straight men and the ones who do not take IV drugs cannot get HIV: Misconception that only gays can get affected by this virus called HIV.

Fact: Though men involved in homosexual sex are more likely to develop HIV, heterosexual contact can also get you affected. Around 3 in 4 women and 1 out of 6 men have this situation.

  • You cannot have children if you’re HIV positive: A very common misconception stating that a HIV positive cannot conceive and extend family.

Fact: It is not necessary that you will not be able to have children if HIV positive. There are certain ways and treatments that can help you conceive. Though HIV is a sexually transmitted disease, there are various options you can consider for conceiving, depending on which partner is HIV positive.

Turacoz Healthcare Solutions aims at spreading awareness regarding HIV/AIDS and debunk any myths or misconceptions surrounding it and make people understand the reality.

Turacoz is a medical communication company and provide services like medical writing, regulatory writing, publication writing,  pharmacovigilance, etc. So, being related to pharma industry, we believe in raising awareness among masses for certain diseases and help them in knowing the truth.

To avail our services or for any query or help, you can contact us at:

[email protected]

It’s about the Blue Circle: Diabetes, its types and challenges

Awareness Day/Month, , , , ,

Not everything sugar is good for you! The overdose of sweetness in your life can be fatal as the threat called ‘Diabetes’ is hovering over the head of millions of people around the globe. It has emerged as the leading cause of blindness, kidney failure and lower limb amputations, globally.

The worldwide commonness of diabetes among grown-ups of the age 18 years and above has ascended from 4.7% in 1980 to 8.5% out of 2014, i.e. 108 million to 422 million.

In 2016, an expected 1.6 million deaths were straightforwardly caused by diabetes. Another 2.2 million deaths were inferable from high blood glucose in 2012. As per WHO estimates, diabetes was the 7th prominent cause of deaths in 2016. Diabetes has been prevalent in the middle and low-income nations.

When talking about Asian countries, India accounts for the most number of diabetic people. As per WHO, India is on the top of the list of the countries with highest number of diabetic people. Currently India represents 49% of world’s diabetic population, with around 72 million cases in 2017 and this figure is expected to rise by more than double by the next decade.

A month dedicated to Diabetes:

The month of November is observed as Diabetes month and November 14th of every year is celebrated as World Diabetes Day in order to raise awareness about Type 1 and Type 2 diabetes, considering the gravity of the ailment.

The theme for the year 2018-2019 is “The Family and Diabetes”.

We all have come across a pink ribbon for breast cancer awareness, a red ribbon for AIDS awareness, etc. The World diabetes is denoted by a Big Blue O.

The blue colour is intended to summon the shade of the sky, and the circle is an image of solidarity. This symbol thus stands for “unite for diabetes”.

What is diabetes?

Diabetes is a critical, long lasting condition where your blood glucose level is extreme. It is chronic disease in which he pancreas either are unable to produce insulin or the body is not able to efficiently use the insulin formed.

Be it any type of diabetes, it holds one thing in common which is that they cause the patients to form extreme level of glucose (sugar) in their blood. It is true that the human body needs glucose as it is the source of energy but excessive formation of it is not good for the body.

Glucose is formed when our body breaks down the carbohydrates which we consume in form of solids or liquids and this glucose is then diffused to the blood. A hormone named ‘Insulin’, secreted by pancreas, helps the glucose in the blood to enter the cells and provide us energy.

A non-diabetic person’s pancreas realizes when the glucose enters the blood and eventually releases the right amount of insulin helping the glucose to enter the cells. This whole process doesn’t function properly in a person affected by diabetes.

The 2 main type of diabetes are: Type 1 and Type 2. They’re diverse conditions, yet they both are serious.

Type 1 and type 2 diabetes:

People with Type 1 diabetes are not capable of making insulin, but the case differs for the person with Type 2 diabetes. The person with latter form of diabetes has either insufficient amount of insulin produced, or the insulin formed doesn’t work effectively. Around 90-95% of a diabetic cases accounts for Type 2 diabetes.

In both types of diabetes, the glucose is unable to enter the cells and thus start accumulating into blood, causing various health issues such as heart problems, issues with eyesight, adverse effect on kidneys, etc.

Symptoms of Type 1 diabetes:

  • Polyuria (increased frequency of urination)
  • Feeling excessively thirsty (polydipsia)
  • Frequent hunger
  • Weight loss
  • Changes in eyesight
  • Tiredness

Symptoms of Type 2 diabetes:

These are almost similar to the Type 1 diabetes but may remain undiagnosed in initial or early stage and hence the complications arise.

Other rare types of diabetes are:

  • Maturity onset diabetes of the young (MODY): A rare types of diabetes that runs in family and is caused by a change or mutation in a single gene. So if any parent has this mutation, there are 50% chances that their child will inherit it from them and even can develop it before the age of 25 irrespective of their weight, lifestyle, etc.
  • Neonatal diabetes: It is spotted under the age of 6 months. In it the mutation of genes affects the insulin formation resulting in a high blood glucose level. Around 20% of people affected by this have developmental delay or epilepsy. It’s different from Type 1 diabetes on the point that Type 1 doesn’t affect a person below the age group of 6 months.
  • Wolfram syndrome: A rare type of genetic disorder which is also acknowledged as DIDMOAD syndrome, pertaining to its 4 common features (Diabetes Insipidus, Diabetes Mellitus, Optic Atrophy & Deafness).
  • Alstrom syndrome: It is also a rare genetically inherited condition which has features like Retinal decay, loss of hearing capacity, obesity, kidney failure, rheumatic problems, etc.

People suffering with Type 2 diabetes have quite a few issues when monitoring their health, like:

  • Monitoring their blood sugar level at regular intervals, throughout the day.
  • Consuming a diabetic-friendly diet
  • Exercising on daily basis to stay fit and maintain weight.
  • Taking the daily dose of medications.
  • Frequently visiting the doctor for check-ups.

What makes this a tedious task is that only 1% of diabetic people’s time is spent under the guidance of a healthcare expert, rest 99% are managing it on their own. Self-management is the toughest form of management.

Adhering to a strict and healthy diet becomes quite a difficult task for people today, considering their hectic life schedule.

The most crucial aspect in case of diabetes is early diagnosis. The prediabetes is very important in determining the factors related to Type 2 diabetes. When talking about the challenges in diabetes diagnosis, the awareness of the disease is the most crucial part. The prediabetes stage is the phase when one needs to get alert in order to avoid further complications in diabetes and reach out for early and timely diagnosis.

What is prediabetes?

It is concerned with the pre-diagnosis of diabetes. It is basically a warning signal for a person whose blood sugar level is higher than normal. Though it is not considered as diabetes, but still implementing a healthy lifestyle from thereon can help reduce the risk of forming Type 2 diabetes later.

By adapting a healthy lifestyle, eating healthy and exercising daily and maintaining a healthy weight can prevent prediabetes from converting into diabetes.

Prediabetes strikes when your body starts encountering trouble with the use of insulin. It is yet not clear as to what causes the insulin process to go astray in some people.

Here are the risk factors that contribute to the development of prediabetes:

  • Weight issues: Being overweight i.e. having a BMI more than 25 can result in prediabetes.
  • Absence of exercise: Not doing any form of physical activity can result into mismanagement of weight and leading to problem like obesity which is the root cause of prediabetes.
  • Family history: If someone in your close blood relation or a family member near to you has diabetes, then you are likely to develop it too, as it is hereditary in nature.
  • Age: Getting older has its own set of cons and one such is the risk of developing diabetes. People with age 45 & above can expect to be at the risk of prediabetes and post 65, this risk increases even more.
  • Other health issues: People with high blood pressure/hypertension are at the risk of getting type 2 diabetes.
  • PCOS: In women, PCOS (Polycystic Ovarian Syndrome), wherein multiple cysts get formed into ovaries, increases the risk of developing prediabetes as one cause for these cysts can be insulin resistance.
  • Gestational diabetes: If a woman has developed diabetes during the pregnancy, there are higher chances of developing prediabetes in the long run.

Challenges in health management during diabetes:

  • Absence of disease arbitration for pre-diabetics: As per American Diabetes Association, the predominance of diabetes has hiked up by 40%, during the last decade. Without any mediation, these numbers will constantly rise in the coming years. 1 in every 3 adults is suffering from prediabetes, but dismally only 7-10% are informed of it. In the absence of intervention, around 30% of such people will fall prey to Type 2 diabetes in a time-span of 3 years.
  • Cohesion with medication: Diabetic people juggle between the costs, avenues, competing arrangements and absence of awareness when they struggling to adhere to the medication.
  • Expensive treatments: The treatment expenses for diabetes are really high. The minimum cost care is impediment, early diagnosis and treatment soon after to minimize the chances of any complications.
  • Inclusion for meds and supplies associated with diabetes: The patients today bear a huge responsibility towards their healthcare costs. Along with the payment of rising insurance premiums, they also have to cope-up with the extra costs of co-pays, co-insurance, etc.

Every problem comes with a solution and so is the case with diabetes. Here are the solutions for the complexities of diabetes management:

  • As mentioned, that early diagnosis is very crucial, staying alert and vigilant about the early symptoms is very important which helps in early detection of diabetes. Symptoms like excessive hunger and urination, excessive thirst, fatigueness, etc. are to be watched out for and in case of any doubt consulting with the physician will help in the diagnostics of prediabetes.
  • A fasting plasma glucose test is used to detect diabetes (126 mg/dl & more) or prediabetes (100mg/dl-125mg/dl) and provides with the measurement of blood glucose, post eating for a minimum of 8 hours.
  • Oral Glucose Tolerance is used to measure blood sugar, post 8 hours of eating anything and post 2 hours of drinking glucose drink. It tests diabetes (200mg/dl & above) and prediabetes (140mg/dl-199mg/dl).
  • There is a random plasma glucose test which in conducted test blood sugar irrespective of when the food is consumed. With particular symptoms like excessive urination, hunger or thirst and weight loss, etc., values of 200mg/dl or more is tested.

Type 1 diabetes is diagnosed earlier as compared to Type 2 diabetes as the symptoms are quite evident and it requires immediate medical care. In case of Type 2 diabetes, the symptoms are too mild to be detected early and can go unnoticed for 7-10 years, inviting more complications and greater health risks.

Now it is about the lifestyle choices that you make. The sedentary lifestyle which people lead today has given birth to various health issues, diabetes being the main. Try to live a more active and healthy lifestyle to prevent yourself against this disease. Healthy eating and healthy living is the key to a healthy life. Being aware regarding the disease can help reduce the risk of its development.

Turacoz Healthcare Solutions-a medical communications company, understands the complexity of diabetes and acknowledges that the hectic schedule of the corporate has fuelled the condition. Turacoz practices a healthy working style for its employees. Practicing desktop yoga, eating healthy and taking breaks in-between work is the culture practiced here. Turacoz values its employees and understands the fact that ‘health is wealth’ and is constantly working towards making work-life healthier for the employees and practicing a active and healthy living style.

Turacoz follows a ‘NO-STRESS’ policy for its employees and believes in keeping the work environment friendly and healthier to avoid any work or workstation related stress and pressure, as stress is also a key factor in triggering diabetes among people.

“Healthy living, healthy eating and healthy working are the mantra for Turacoz Healthcare Solutions”.