Monthly Archives: April 2016

World Malaria Day : Understanding Malaria

Awareness Day/Month, , , , , ,

Malaria is a serious life-threatening parasitic disease caused by parasites known as Plasmodium vivax (P.vivax), Plasmodium falciparum (P.falciparum), Plasmodium malariae (P.malariae) and Plasmodium ovale (P.ovale). Its transmission takes place through the infective bite of Anopheles mosquito. Man develops this disease after 10–14 days of being bitten by an infective mosquito.

Every year April 25 is celebrated as “World Malaria Day” across the globe in an effort to provide effective control of the disease. This occasion also provides a common platform for the affected countries to share experiences, showcase technologies and collaborate in programs in the fight against malaria.

SIGNS AND SYMPTOMS OF MALARIA

Symptoms of malaria include fever and flu-like illness, including shaking chills, headache, muscle aches, and tiredness. Nausea, vomiting, and diarrhea may also occur. Malaria may cause anemia and jaundice (yellow coloring of the skin and eyes) because of the loss of red blood cells. Infection with one type of malaria, P. falciparum, if not promptly treated, may cause kidney failure, seizures, mental confusion, coma, and death.

POPULATION AT RISK

In 2015, approximately 3.2 billion people—nearly half of the world’s population—were at risk of malaria.

Maximum number of malaria cases and deaths occur in sub-Saharan Africa. However, Asia, Latin America, and, to a lesser degree, the Middle East, are also at risk. In 2015, 97 countries and territories had ongoing malaria transmission.

DISEASE BURDEN

  • According to the latest WHO estimates, released in December 2015, there were 214 million cases of malaria in 2015 and 438,000 deaths.
  • Between 2000 and 2015, malaria incidence among populations at risk reduced by 37% globally; during the same period, malaria mortality rates among populations at risk registered a decline by 60%. An estimated 6.2 million malaria deaths have been averted globally since 2001.
  • Sub-Saharan Africa continues to contributethe highest share of the global malaria burden. In 2015, the region accounted for 88% of malaria cases and 90% of malaria deaths.

PREVENTIVE MEASURES FOR CONTROLLING MALARIA

  • Taking antimalarial drugs to kill the parasites
  • Eliminating places where mosquitoes breed
  • Spraying insecticides to kill adult mosquitoes that come inside
  • Sleeping under bed nets—especially effective if they have been treated with insecticide, e.g. insecticide-treated mosquito nets (ITNs) and
  • Wearing insect repellent and long-sleeved clothing if out of doors at night.

CURRENT SCENARIO OF MALARIA VACCINE

  • Effective malaria vaccine could helpeliminate and eradicate malaria; there are currently 63 vaccine candidates, 41in preclinical and clinical stages of development.
  • Vaccines are being designedto target pre-erythrocytic stages, erythrocytic stage or the sexual stages ofPlasmodium taken up by a feeding mosquito, or the multiple stages
  • Twovaccines in preclinical and clinical development target falciparum; and themost advanced candidate is the pre-erythrocytic vaccine RTS,S which is inphase-III clinical trials.
  • RTS,S/ASO1 is the first malaria vaccine to have completed pivotal Phase 3 testing and obtained a positive scientific opinion by a stringent medicines regulatory authority.
  • Collaborators of RTS,S Clinical Trials Partnership showed that RTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3–4-year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission.

Turacoz Healthcare Solutions is committed to spread the awareness on such social or healthcare related issues as a part of their Corporate Social Responsibility (CSR) activity. Our medical writing team is well versed with recent advances in various therapeutic areas which gives them a head start in various publication, clinical research and regulatory writing projects.

Medical Writing Workshop at Bangalore

News

5b79d27d-7530-4423-be85-44dc1dc89c0d-originalTuracoz Healthcare Solutions conducted a medical writing workshop on 16th April, 2016 at Country Inn and suites by Carlson, Bangalore. The workshop primarily focused on publication where subjects like grammar, guidelines, biostatistics, referencing etc. were the topics of discussion. Doctors from the reputed hospitals, medical writers, medical managers and advisors from the pharmaceutical industry were the main audience. Live assignments and case studies made the session highly interactive where people came forward with their queries. The workshop was highly appreciated and valuable feedbacks were received.

World Hemophilia Day

Awareness Day/Month

Let’s Join Hands to Fight Against Hemophilia

Hemophilia is one of the oldest known genetic bleeding disorder which is caused by deficiency of the genes responsible for synthesis of clotting factors. Clotting factors are special type of proteins required for blood clotting. If a person does not have enough clotting factor VIII, then the condition is known as “hemophilia A”, while deficiency of clotting factor IX is known as “hemophilia B”.

Misconception                Individuals with hemophilia bleed faster than normal people

    Fact                             Individuals with hemophilia bleed longer than normal people

 

The major symptoms of hemophilia are: prolonged bleeding, spontaneous bleeding, bleeding into joints and muscles, excessive bleeding following trauma or surgery, easy bruising, swelling, pain, and stiffness. Left untreated, it can lead to various life-threatening complications like deep internal bleedings, joint damage, and intracranial hemorrhage. However, there are various treatment options available for the disorder like replacement therapy with clotting factors, gene therapy and anti-fibrinolytic medicines. Unfortunately, a large population of hemophilic patients is unable to receive adequate treatment due to its high cost.

Although the incidence of hemophilia is low and is estimated to affect approximately 1 in 10,000 people, only 25 % of those living with hemophilia get proper care.

 

World Hemophilia Day (WHD) is, therefore, a day to consider those hemophilic patients who are unable to access the care and treatment they require to live a healthy life.

History: WHD was established in 1989 with the help of the World Federation of Hemophilia (WFH). Since 1989, WHD is observed globally on April 17 in order to honor Frank Schnabel, the founder of WFH, whose birthday falls on the same date. Today, WHD has grown into a global event which is celebrated across 113 WFH member countries.

 

“Treatment for all is the vision of all” is the main goal of WHD.

The main aim of WHD is to increase public awareness, educate patients, attract volunteers, and advocate for improved treatment and care of hemophilia. This day provides an opportunity to talk to your family, friends, and colleagues to raise awareness and increase support for the patients living with hemophilia and other bleeding disorders.

A patient with hemophilia must be encouraged to think and act positively. Since hemophilia is a lifelong condition, requires expensive treatment, and affects patient’s family life, therefore, it is important that parents, spouses, and other family members of the patient should be educated in all aspects of the patient’s care. Besides, general information and education should also be given to the community where hemophilic patient lives.

Today, someone born with hemophilia can live a normal life if he/she has access to adequate treatment. Although access to adequate treatment is a big challenge but the WFH has a vision and is trying hard to provide treatment for all the people with hemophilia.

Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) – Code for Writing Promotional Material

Medical Writing

The Department of Pharmaceuticals (DoP), Government of India, released Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) on 1st January 2015.
UCPMP is a voluntary code that should be adopted by pharmaceutical industry to curb unethical practices in the healthcare sector. UCPMP bears significance as pharmaceutical companies have been accused of massive enticements to secure prescriptions from the medical fraternity for a very long time.

UCPMP for promotional materials:

  • All promotional material issued by a product authorization holder or with his authority, must be consistent with the requirements of this Code.
  • Where the purpose of promotional material is to provide persons qualified to prescribe or supply with sufficient information upon which to reach a decision for prescribing or for use, then the following minimum information, must be given clearly and legibly and must be an integral part of the advertisement:
    • The relevant product authorization number and the name and address of the holder of the authorization or the business name and address of the part of the business responsible for placing the medicinal product on the market
    • The name of the product, and a list of the active ingredients, using the common name, placed immediately adjacent to the most prominent display of the name of the product
    • Recommended dosage, method of use and, where not obvious, method of administration
    • Adverse reactions, warnings and precautions for use, and relevant contraindications of the product
    • A statement that additional information is available on request
    • The date on which the above particulars were generated or last updated
  • Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a pharmaceutical company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble editorial matter.
  • Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognize the professional standing of the recipients and not be likely to cause any offence.
  • The names or photographs of healthcare professionals must not be used in promotional material.
  • Promotional material must not imitate the devices, copy, slogans, or general layout adopted by other companies in a way that is likely to mislead or confuse.
  • Where appropriate (for example, in technical and other informative material), the date of printing or of the last review of promotional material must be stated.
  • Extremes of format, size, or cost of promotional material must be avoided.
  • Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the lay public or which could be considered unsuitable for public view.
  • Audio-visual material must be accompanied by all appropriate printed material so that all relevant requirements of the Code are complied with.

Other key highlights of UCPMP are:

  • No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc.
  • Free samples of drugs shall not be supplied to any person who is not qualified to prescribe such products
  • Companies or their associations/representatives or any person acting on their behalf shall not extend any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals and their family members for vacation or for attending conference, seminars, workshops, etc. as a delegate
  • Companies should not pay any cash or monetary grants to any healthcare professionals for individual purpose in individual capacity under any pretext
  • Funding for medical research, study etc., can only be extended through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner

Need for UCPMP – Self-regulation in pharma marketing has hardly worked anywhere

Many international pharmaceutical trade associations, which are primarily the lobbying bodies, strongly advocate self-regulations (such as following UCPMP) by the industry. They have also created many documents in this regard, which are also displayed in their respective websites. However, despite all this, the ground reality is that, the well-hyped self-regulation by the industry to stop the menace of pharma marketing malpractices is not working; few recent examples are cited below:

  • March 2014 – the anti-trust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • March 2014 -A German court fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • May 2013 – Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix.
  • August 2012 – Pfizer Inc. was reportedly fined US$ 60.2 million by the US Securities and Exchange Commission to settle a federal investigation on alleged bribing of overseas doctors and other health officials to prescribe medicines.
  • April 2012 – a judge in Arkansas, US, reportedly fined Johnson & Johnson and a subsidiary more than US$1.2 billion after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug.

As per the recent information available, the government is planning to make the UCPMP practices mandatory, which have so far been voluntary. The DoP is working on to finalize the mandatory code practices. The move has been triggered by insufficient compliance to the existing voluntary code by pharmaceutical companies. The mandatory codes will also involve legal implications and invoking of marketing licenses.

Turacoz healthcare solutions fully believe in following ethical codes such UCPMP. Our medical writing team is well versed with these codes and tries to adapt to the same while providing promotional material content to our client.

Autism Awareness Month: The Challenges and Promises of Childhood Neurodisability

Awareness Day/Month

Autism is a serious, lifelong developmental disability characterized by considerable impairments in social interactions and communication skills, as well as a restricted/repetitive pattern of interests and/or behaviors. The term autism is also confused with the other autism spectrum disorder (ASD) including classic autism, Asperger syndrome and high-functioning autism. Autism used to be considered rare, but it is increasingly recognized as a relatively common condition.
Both genetic and epidemiological research findings have forced a change in concept as a result of the evidence that autistic like abnormalities are common and often occur in individuals with normal intelligence, particularly in first degree relatives of individuals with autism.

Autism and other forms of disability are part of the human experience that contributes to human diversity. An integral approach in the design, implementation, monitoring and evaluation of policies and programme in all political, economic and societal spheres, so that inequality is not perpetuate

Neurodevelopment Course of Autism at a Glance

  • Recent neurobiological data suggests that autism is caused by late disruption of the central nervous system (CNS) just prior to birth, perinatally, or postnatally.
  • The limbic system plays a significant role in various aspects of emotion, memory and learning, and motivation. Studies indicate that the neural cells of the limbic system in autism are small in size and more densely packed per unit volume as compared with age and sex-matched controls.
  • The second major area of abnormality found was in the cerebellum and its many circuits and interconnections. Basically they found a substantial loss of Purkinje cells throughout the cerebellum, especially in the posterior regions. The loss of Purkinje cells helps establish the timing of the abnormalities.

 

Reader’s Interest

  • Autism is one of the fastest-growing developmental disorders in the U.S.
  • Autism costs a family $60,000 a year on average.
  • There is no medical detection or cure for autism.
  • Total 2012 National Institute of Health (NIH) budget: $30.86 billion, only $169 million goes directly to autism research. This represents 0.55% of total NIH funding.
  • ASD is reported to occur in all racial, ethnic, and socioeconomic groups.
  • ASD is about 4.5 times more common among boys (1 in 42) than among girls (1 in 189).
  • The total costs per year for children with ASD in the United States were estimated to be between $11.5 billion – $60.9 billion.

 

Symptoms

The characteristic behaviors of ASD may be apparent in infancy (18 to 24 months), but they usually become clearer during early childhood (24 months to 6 years). The National Institute of Child Health and Human Development (NICHD) lists five behaviors that warrant further evaluation:

  • Does not babble or coo by 12 months
  • Does not gesture (point, wave, grasp) by 12 months
  • Does not say single words by 16 months
  • Does not say two-word phrases on his or her own by 24 months
  • Has any loss of any language or social skill at any age?

2 % of children in the U.S. are living with autism. The earlier they have access to care, services and treatment, the more likely they are to progress

Diagnosis Tests

Early identification is associated with dramatically better outcomes for people with autism. The Centers for Disease Control and Prevention’s (CDC) National Center on Birth Defects and Developmental Disabilities (NCBDD) recommends that all children be screened for autism by their family pediatrician three times by the age of 3, 9, 18, and 24 or 30 months. Treatment should start when an autism diagnosis is suspected, rather than when a formal diagnosis is made.

  • Behavioral assessments: Guidelines and questionnaires are used to help a doctor determine the specific type of developmental delay.
  • Diagnostic guidelines for autism: The American Association of Childhood and Adolescent Psychiatry (AACAP) have established guidelines for diagnosing autism. The criteria are designed so a doctor can assess a child’s behavior relating to core symptoms of autism such as:
    • Clinical observations: The parents may be asked to interpret whether certain developmental delayed behaviors are usual for the child in those circumstances.
    • Developmental and intelligence tests: To evaluate whether a child’s developmental delays affect his or her ability to think and make decisions.
    • Physical examination: Head circumference, weight, and height measurements, to determine whether the child has a normal growth pattern.
    • Hearing tests: To determine whether hearing problems may be causing developmental delays, related to social skills and language use.
    • Testing for lead poisoning: Children with developmental delays usually put items in their mouth after this stage has passed in normally developing children, which should be identified and treated.
    • Chromosomal analysis, if intellectual disability is present or there is a family history of intellectual disability.
    • An electroencephalograph (EEG), if there are symptoms of seizures, such as a history of staring spells or if a person reverts to less mature behavior (developmental regression).
    • Magnetic Resonance Imaging, if there are signs of differences in the structure of the brain.

 

According to Volkmar et al., Autism Spectrum may be distinguished from autism and pervasive developmental disorder- not otherwise specified (PDD-NOS) on the basis of higher verbal IQs, greater social deficit, higher rates of the disorder in first-degree relatives, and different patterns of co-morbidity, especially higher rates of depression.

Risk Factors

  • In identical twins, if one child has ASD, then the other will be affected about 36-95% of the time whereas in non-identical twins, if one child has ASD, then the other is affected about 0-31% of the time.
  • Almost half (about 44%) of children identified with ASD has average to above average intellectual ability.
  • A small percentage of children who are born prematurely or with low birth weight are at greater risk for having ASD.
  • ASD commonly co-occurs with other developmental, psychiatric, neurologic, chromosomal, and genetic diagnoses.
  • Children born to older parents are at a higher risk for having ASD.

The best evidence suggests that early, intensive behavioral and educational interventions can improve outcomes for many children with ASD. While there are no medications that target the primary social or repetitive behavior symptoms

Research Gaps

  • Following the emphasis on early identification and early intervention, question has been arising what are the earliest emerging signs of autism? what are the internal and external factors associated with outcomes? What are the emerging early intervention approaches for which the best evidence-base exists? Despite the increase in well-controlled intervention studies, further such trials are required to improve the evidence-base for established and newer interventions.
  • Only recently have longitudinal studies begun to examine the trajectories of social development beyond midchildhood into adolescence and adulthood.
  • Mechanistic studies that employ experimental and neuroscientific methodologies, where possible embedded within genetic and familial designs, are required to elucidate the neurodevelopmental processes that lead to the social difficulties in autism.
  • Such studies will also help us to understand the associations between social difficulties and common comorbidities in adaptive function, sensory difficulties and mental health problems.

 

Current research: Holds new hope for the treatment of autism

  • Researchers have identified a number of genes associated with the disorder and brain-imaging studies have found differences in the development of several regions of the brain. Findings suggest that ASD can result from disruptions in genes that control aspects of brain development or control how brain cells communicate with each other.
  • New and novel approaches began enrolling participants in a clinical trial to test oxytocin (via a nasal spray) for individuals with autism. For nearly 10 years, there have been studies showing that administering oxytocin, a medication and hormone used to start and increase the speed of labor in pregnancy, may change response to social cues in the laboratory setting.
  • The clinical trial at NewYork-Presbyterian (NYP/Westchester Division), which will test individuals between the ages of 3 and 17, will evaluate whether oxytocin may offer benefit as a potential treatment for those on the autism spectrum, while paying careful attention to whether oxytocin is safe for repeated administration.
  • The currently available instruments like Autism Diagnostic Interview – Revised, Autism Diagnostic Observational Schedule, and Childhood Autism Rating Scale are not specific to these criteria. So, there is also a need to develop an instrument with high fidelity to international classification of diseases (ICD-10)/ diagnostic and statistical manual of mental disorders (DSM-IV) description/criteria

Turacoz Healthcare Solutions is passionate to spread the awareness on such social or healthcare related issues as a part of their Corporate Social Responsibility (CSR) activity. CSR is at the very heart of everything we do at Turacoz. It is exclusive in a way we deal with our communities, our people, our clients and our environment. Our medical writing team is well versed with recent advances in various therapeutic areas which give them a head start in various publication, clinical research and regulatory writing projects.

World Parkinson’s Disease Day: Shatter the Myths with Hope

Awareness Day/Month,

World Parkinson’s Disease Day: 11th April, 2016:

World Parkinson’s disease day is celebrated every year on 11th April to commemorate Dr. J Parkinson on his birthday. He was the first to describe the disease in “An Essay on the Shaking Palsy”, as a disorder with a pattern of lessened muscular power and involuntary tremulous motion. On this day, efforts are made to increase the public awareness of this terrible disease.

 

What Is Parkinson’s Disease?

Parkinson’s disease (PD) is a neurodegenerative disorder which affects the nerve cells in the brain that produce dopamine. As a result, these nerve cells are reduced in numbers. As cell death spreads to larger parts of the brain more centers are affected which results in an aggravated motor and non-motor functional impairments. It is a progressive disorder and the symptoms gradually worsen.

Symptoms of PD begin gradually, often on one side of the body and later, they affect both sides of the body. The disease is characterized by:

  • Trembling of hands, arms, legs, jaw and face
  • Stiffness of the arms, legs and trunk
  • Slowness of movement and trouble in walking and/or talking
  • Poor balance and coordination
  • Sleep problems and depression

People with the disease may have trouble doing simple tasks as the symptoms get worse. They may also have trouble chewing, swallowing, or speaking.

 

Screening and Diagnosis

PD usually begins around age 60, but it can start earlier. It is more common in men than in women. There is no laboratory test for PD, so it can be difficult to diagnose. Doctors use a medical history and a neurological examination to diagnose it. There is no cure for PD

 

Lifestyle Remedies and Health Care Solution

  • Exercise: It may increase your muscle strength, flexibility and balance. Exercise can also improve your well-being and reduce depression or anxiety
  • Medications: They may help you manage problems with walking, movement and tremor. Medications can help control the PD- symptoms by substituting/increasing for dopamine in the brain.
  • Healthy diet: A balanced diet provides nutrition. Foods such as fish which contain omega-3 fatty acids are also recommended for persons with PD.
  • Training for daily activities: An occupational therapist can show techniques that make daily life easier.
  • Be careful while walking: At later stages of the disease, movement can become difficult. Distribute your weight evenly between both feet, and don’t lean. Avoid walking backward.

 

Create Awareness to Find a Cure:

Many people are not fully aware of how to identify PD. In the interest of promoting awareness of this disease, we can:

  • Organize larger events at local parks, or even with local schools for the cause of PD
  • Work together to create a day where there are educational courses about the disease
  • Arrange for musical performances, conduct marathons and walk-a-thons to help generate donations to support the ongoing research into this condition.
  • Work together with friends and family to help organize refreshment stands or bake sales to produce more funds to donate to research groups

Turacoz Healthcare Solutions is committed to spread the awareness on such social or healthcare-related issues as a part of their Corporate Social Responsibility (CSR) activity. Our medical writing team is well-versed in various therapeutic areas which gives them a head start in various publication, clinical research and regulatory writing projects.