Timely hepatitis B vaccination is key to preventing chronic liver disease

Hepatocellular liver carcinoma is the third leading cause of annual deaths due to cancer

New Delhi, 10^th December 2018: Most liver diseases are silent. By the time the symptoms appear, there is already about 50% or more damage done. In the absence of timely detection and treatment, cirrhosis (scarring) of the liver sets in, especially in viral Hepatitis B and C.

Apart from this, in cirrhotic cases, tumor may develop any time. In about 70% of the cases, cirrhosis leads to liver cancer, which is one of the fastest growing cancers today.

An effective vaccination programme plays an important role in preventing HBV infection. It is known to decrease the incidence of chronic liver disease and hepatocellular carcinoma (HCC) or liver cancer.

The vaccination protocol

1^st Vaccine: Zero day

2^nd Dose: Between 1-2 months

3rd Dose: Between 4-6 months

Speaking about this, Padma Shri Awardee, Dr KK Aggarwal, President, Heart Care Foundation of India said, “The liver helps in removing toxins and other chemical waste products from the blood and readying them for excretion. As all the blood in the body passes through it, the liver is unusually accessible to cancer cells traveling in the bloodstream. The liver is made up of several kinds of cells, due to which different types of tumors can form there. They could be benign (noncancerous), or cancerous and can spread to other parts of the body (metastasize). These tumors have different causes and are treated differently. More than half of all people diagnosed with primary liver cancer have cirrhosis — a scarring condition of the liver commonly caused by alcohol abuse.”

Some common symptoms of liver cancer include loss of weight and appetite; nausea or vomiting; enlarged liver and spleen; pain in the abdomen or near the right shoulder blade; swelling or fluid build-up in the abdomen; itching; and yellowing of the skin and eyes (jaundice).

Adding further, Dr Aggarwal, who is also the Group Editor-in-Chief of IJCP, said, “There are 4 main T stages – T1 to T4. The main factors that doctors take into account are the size of the liver tumours and whether the cancer has grown into any blood vessels in the liver. This may mean that the cancer is obviously growing into or around a vein or artery. Or it may mean that there is microscopic growth of cancer cells into the vein or artery wall.”

Some tips from HCFI

• Limit the use of alcohol and tobacco. If you cant go for harm reduction
• Consumption of excess alcohol is a major risk factor for developing liver cancer over a period of time.
• Eat healthy and consume plenty of fruits, vegetables, and whole grains. These are rich in antioxidants and prevent the formation of free radicals in the body.
• Aim to get at least 30 minutes of exercise every day. This will not only keep you fit but also reduce excess weight.
• Get vaccinated for Hepatitis B.

Missed doses — An interruption in the vaccination schedule does not require restarting the entire series of vaccination or adding extra doses.

If the vaccination series is interrupted after the first dose the second dose should be administered as soon as possible

For those receiving a three-dose series, the second and third doses should be separated by an interval of at least two months. If only the third dose is delayed, it should be administered when convenient.

Longer than recommended intervals between doses do not reduce final antibody concentrations, although protection might not be attained until the recommended number of doses has been administered

Never go against the recommendations of the manufacturer

All drugs/devices are accompanied with labeling or full prescribing information or the package insert, which includes directions for use, warning and precautions and dosage and administration. This package insert is for the doctor as the “learned intermediary”, who can evaluate this information and sift out that which is relevant for his patient and accordingly balance the dangers of the drug against the benefits of its use. This is because prescription drugs and devices can be obtained by patients only when prescribed by their treating doctor. So, once the doctor has been warned, the duty to use the drug properly and to warn the patient about any risks is lies upon the physician.

One should never go against manufacturer’s recommendation or DCGI approval, with regard to:

·         Dose of a drug as approved by DCGI

·         Indication/s approved by DCGI

·         Reuse of disposables or device if written “for single use only”

·         Off label use of a drug needs informed consent

If you do not do so, it will be termed as a trial and will require informed consent and approval of the institutional ethics committee.  

In the case of Balram Prasad vs Kunal Saha & Ors on 24 October, 2013 in the Supreme Court of India: Civil Appellate Jurisdiction: Civil Appeal No.2867 of 2012, the Apex Court has held as follows:

“73. He has also placed reliance upon in justification of his claim of exemplary or punitive damages. A claim of US $ 1,000,000 as punitive damages has been made against the AMRI Hospital and Dr. Sukumar Mukherjee as provided in the table. In support of this contention he placed strong reliance on Landgraf Vs. USI Film Prods [29] and this Court’s decision in Destruction of Public and Private Properties Vs. State of A.P.[30], wherein it is held that punitive or exemplary damages have been justifiably awarded as a deterrent in the future for outrageous and reprehensible act on the part of the accused. In fact punitive damages are routinely awarded in medical negligence cases in western countries for reckless and reprehensible act by the doctors or Hospitals in order to send a deterrent message to other members of the medical community. In a similar case, the Court of Appeals in South Carolina in Welch Vs. Epstein[31] held that a neurosurgeon is guilty for reckless therapy after he used a drug in clear disregard to the warning given by the drug manufacturer causing the death of a patient. This Court has categorically held that the injection Depomedrol used at the rate of 80 mg twice daily by Dr. Sukumar Mukherjee was in clear violation of the manufacturer’s warning and recommendation and admittedly, the instruction regarding direction for use of the medicine had not been followed in the instant case. This Court has also made it clear that the excessive use of the medicine by the doctor was out of sheer ignorance of basic hazards relating to the use of steroids as also lack of judgment. No doctor has the right to use the drug beyond the maximum recommended dose.

111. “159. When Dr. Mukherjee examined Anuradha, she had rashes all over her body and this being the case of dermatology, he should have referred her to a dermatologist. Instead, he prescribed “depomedrol” for the next 3 days on his assumption that it was a case of “vasculitis”. The dosage of 120 mg depomedrol per day is certainly a higher dose in case of a TEN patient or for that matter any patient suffering from any other bypass or skin disease and the maximum recommended usage by the drug manufacturer has also been exceeded by Dr. Mukherjee. On 11-5- 1998, the further prescription of depomedrol without diagnosing the nature of the disease is a wrongful act on his part.

147. Therefore, a total amount of Rs.6,08,00,550/- is the compensation awarded in this appeal to the claimant Dr. Kunal Saha by partly modifying the award granted by the National Commission under different heads with 6% interest per annum from the date of application till the date of payment.”

So, before prescribing a drug, read the manufacturer/DCGI recommendations and prescribe the dose and/or use the device as per those recommendations. Failure to do so may make you liable for medical malpractice.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

Low-allergenicity landscaping plant selection criteria for patients with pollen-related allergies

Patients with pollen-related allergic rhinoconjunctivitis or asthma and landscapers sometimes enquire about modifying outdoor environments to choose plants that are less likely to trigger symptoms. However, there are only few information sources available to help them identify allergenic plants and strategies to avoid personal exposure to them

Now, the Landscape Allergen Working Group of the American Academy of Allergy, Asthma and Immunology has created a guide, which for the first time lists plants of low allergenic potential and also provides general guidance on creating a low-allergenic landscape.

In general, trees, shrubs, and flowering plants with heavier versus lighter pollen are less allergenic, because heavier pollen is transported by insects rather than traveling through the air.

Published in the Journal of Allergy and Clinical Immunology: In Practice, the Working Group says that to avoid selecting plant species that could exacerbate seasonal allergies in individuals sensitized to them, the following selection criteria/guidelines should be considered during the design stages of a low-allergenic landscape:

·         Eliminate existing anemophilous species from your landscape if possible. Reduce grass pollen exposure and consider placement of shrubs or hardscaping.

·         Grass allergens may also become aerosolized in the absence of pollen with mowing, in combination or not with rainfall episodes.

·         Select a broad diversity of entomophilous, low-allergen producing species with little seasonal pollen production

·         Ensure that selected species do not cross-react with other characterized allergenic plant species to the best possible extent

To minimize exposure to biologic hazards, precautionary steps should be taken:

·         Wear protective clothing and equipment including long-sleeved shirts, long pants, gloves, and head and eye protection.

·         Apply insect repellent to prevent insect exposure and stings. Wear respiratory protection during disturbance activities such as digging soil, distributing mulch or compost, and mowing.

·         Carry self-injectable epinephrine for those susceptible to anaphylaxis following an insect sting.

·         Be aware of the season and potential exposure to pollen from neighboring areas.

·         Remove poison ivy (Toxicodendron radicans) or other plants identified to cause skin injuries and toxic reactions.

·         Landscaping employers should educate workers about pollen exposure and other biological hazards

“Although a completely allergy-free garden space outdoors is unrealistic, a reduced allergen or low-allergen landscape is feasible to design using the information and principles described”

(Source: Green BJ, Levetin E, Horner WE, et al. Landscape plant selection criteria for the allergic patient. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):1869-1876).

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

Leading Veterinary organizations issue joint statement on antimicrobial resistance: Asian NMOs should join

Veterinary organizations in North America and Europe have teamed up to combat antimicrobial resistance.

The American Veterinary Medical Association (AVMA), the Canadian Veterinary Medical Association (CVMA) and the Federation of Veterinarians of Europe (FVE) issued a “Joint Statement on Continuous Monitoring of Antimicrobial Use & Antimicrobial Resistance” on Thursday, Dec. 6 that describes broad steps and strategies veterinarians around the world can take to preserve the effectiveness and availability of antimicrobial drugs while safeguarding animal, public and environmental health. 

In its guideline published last year, the WHO had strongly recommended “an overall reduction in the use of all classes of medically important antibiotics in food-producing animals, including complete restriction of these antibiotics for growth promotion and disease prevention without diagnosis. Healthy animals should only receive antibiotics to prevent disease if it has been diagnosed in other animals in the same flock, herd, or fish population. And, where possible, sick animals should be tested to determine the most effective and prudent antibiotic to treat their specific infection. Antibiotics used in animals should be selected from those WHO has listed as being “least important” to human health, and not from those classified as “highest priority critically important”. These antibiotics are often the last line, or one of limited treatments, available to treat serious bacterial infections in humans”.

The major recommendations made by the veterinary organizations are as follows:

• All countries shall have a robust regulatory system in place in respect to the authorization and manufacture of human and veterinary medicines including antimicrobials.
• A legislative system shall be in place to regulate the distribution and sales of these medicinal products.
• Illegal manufacture, distribution or sales of medicines shall be prosecuted.
• Medically or critically important antimicrobials shall be administered to animals only with the oversight
• A robust global network of surveillance and monitoring systems for antimicrobial use and resistance development shall be established.
• Antimicrobial use shall be monitored both in the human and animal health sectors and any other sector in which antimicrobials are used.
• The levels of antimicrobial resistance shall be monitored in people, animals, food products and the environment.
• Easily available, effective, rapid and standardized diagnostic tests shall be available in order to carry out susceptibility testing.
• The use of modern techniques such as genomics, which trace the origin and circulation of bacterial strains, should be promoted as appropriate in accordance with available resources. Sufficient funding shall be available for further research and development of rapid and affordable diagnostic tests.
• Veterinarians must retain access to effective antimicrobials for therapeutic purposes for animals suffering from a bacterial disease in order to safeguard animal health and welfare and public health; therefore, antimicrobials must not be unilaterally limited for use in humans only

Antimicrobial resistance does not recognize borders, which means that only a concerted effort could curtail its spread and prevent its evolution.

As President-Elect of CMAAO, the Confederation of Medical Associations of Asia and Oceania, it shall be my endeavor that all National Medical Associations under CMAAO attempt joining hands with the campaign and make it a success.

India should take the lead in this movement.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

Central obesity is very prevalent in persons at high risk of heart disease and stroke

Results of the European Society of Cardiology (ESC) EUROASPIRE V survey presented yesterday at the World Congress of Cardiology & Cardiovascular Health in Dubai, UAE show that almost two-thirds of people at high risk of heart disease and stroke have excess belly fat or central obesity. EUROASPIRE is a series of cross sectional surveys on the prevention of heart disease in ESC member countries.

The survey found that almost two-thirds (64%) were centrally obese, with waist circumference ≥88 cm for women and ≥102 cm for men). Some 37% were overweight (body mass index [BMI] 25-29.9 kg/m2) and 44% were obese (BMI ≥30kg/m2 ).

Less than half (47%) of those on antihypertensive medication achieved the target BP of less than 140/90 mmHg (less than 140/85 mmHg in patients with self-reported diabetes). And, only 43% of the participants on lipid-lowering drugs attained the LDL cholesterol target of less than 2.5 mmol/L, while 65% of those being treated for type 2 diabetes achieved the A1c target of less than <7.0%.

About 18% were smokers and just 36% achieved the recommended physical activity level of at least 30 minutes, five times per week.

The EUROASPIRE V was conducted in 2017 to 2018 in 78 general practices in 16 primarily European countries and involved 2,759 participants. Each general practice enrolled consecutive individuals under the age of 80 years with no history of coronary artery disease or other atherosclerotic disease, but who were at high risk of developing CVD. High risk was defined as having high BP, high cholesterol, and/or diabetes; the study therefore recruited individuals who had been prescribed antihypertensive, lipid-lowering, and/or anti-diabetes treatments (diet and/or oral hypoglycemics and/or insulin).

BMI is generally used as a measure of obesity. It takes into consideration height and body weight, but not body fat.

A correct measure of obesity therefore is via measurement of body fat, especially the fat around the abdomen. A high waist-to-hip ratio indicates high amounts of abdominal fat. A person can be obese even if the body weight is within the normal range. This is called normal weight obesity, where the BMI is normal as per the age and height, but the body fat percentage is high. Typically, such individuals have a potbelly but otherwise appear normal. Abdominal obesity is more dangerous than generalized obesity.

Any weight gain after puberty is invariably due to fat as most organs also stop growing, once the height stops increasing. One should not gain weight of more than 5 kg after the age of 20 years in males and 18 years in females. And, after the age of 50, the weight should reduce and not increase.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

Guidelines may underestimate the harms of statins: Follow person-centric approach

A new modelling study involving persons aged 40 to 75 years with no history of cardiovascular disease (CVD) suggests that 10-year risk thresholds used in current guidelines to prescribe statins for primary prevention of CVD are probably substantially too low.

A new study published online Dec 3, 2018 in the Annals of Internal Medicine has suggested that instead of 7.5% to 10% 10-year risks one should use 14% risk thresholds where the benefits of statins exceed the harms.

Using an approach originally developed by the National Cancer Institute to look at tamoxifen for breast cancer prevention, the investigators show that statins provide net benefits at higher 10-year risks for CVD than are reflected in most current guidelines; 14% for men aged 40 to 44 years. The risk threshold, however, increased to 21% for aged 70 to 75. For women, the risk thresholds were higher at 17% and 22%, respectively. Individuals, who were at high risk for CVD (>21%) were likely to benefit from statins, regardless of sex or age.

Among the four commonly used statins, atorvastatin was found to have the most favorable benefit–harm balance, followed by rosuvastatin, especially for younger adults with low or medium CVD risk.

New research and/or guidelines are suggestions and recommendations, which are definitely evidence-based. While they do standardize treatment for any given condition, they are not without their limitations. They cannot be generalized as each patient is different and hence treatment has to be individualized.

Also, western data cannot be extrapolated to our Indian settings.

Do not follow guidelines blindly and give statins to every case with 10-year risk of heart disease of more than 10%.

Instead every case should be individualized based on age  and other factors.

The individual risk for CVD events should be calculated before prescribing statins. This will result in individual patient harm reduction in CVD risk.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

Air pollution should now be labelled as a “potentially modifiable” risk factor

It seems that the issue of air pollution is here to stay. Now, a study reported in The Lancet Planetary Health has attributed one in every eight deaths in India to air pollution, which is now believed to contribute to more disease burden than smoking. This study is the first comprehensive estimates of deaths, disease burden, and life expectancy reduction associated with air pollution in each state of India by the India State-Level Disease Burden Initiative.

India is home to about 18% of the world population, but it has a disproportionately high 26% of the global premature deaths and disease burden due to air pollution. Over half of the 12.4 lakh deaths in India attributable to air pollution in 2017 were in persons younger than 70 years.

The study further goes as far as saying that the average life expectancy in India would have been 1.7 years higher if the air pollution level were less than the minimal level causing health loss.

India has one of the highest annual average ambient particulate matter PM2.5 exposure levels in the world. While, the WHO recommended levels for PM 2.5 are less than10 μg/m³, the limit set by National Ambient Air Quality Standards of India is PM2.5 less than 40 μg/m³.

The WHO says that 14 of the 15 cities with the worst air pollution in the world are in India.

Last year, the annual population-weighted mean exposure to ambient particulate matter PM2.5 in India was 89.9 μg/m3. Around 77% of the population of India has been found exposed to annual population-weighted mean PM2.5 greater than 40 μg/m3. Delhi had the highest annual population-weighted mean PM2.5 in 2017, followed by Uttar Pradesh, Bihar, and Haryana in north India. All had mean values greater than 125 μg/m3. Of the 1.24 million deaths attributable to air pollution, more than half were people below 70 years.

Air pollution adds to the global burden of disease. Poor air quality has been shown to be associated with NCDs such as heart disease, asthma, COPD, cancer, making it a major public health problem of concern. It is not only associated with morbidity but also mortality due to these diseases. A study published only this month has shown a link between air pollution and increased risk for miscarriage.

Pollution is also a source of infection. Bioaerosols are among the environmental pollutants, which may be responsible for airborne disease transmission. Any negligent or malignant act likely to spread infection of disease dangerous to life is a punishable offence under sections 269 and 270, respectively, of the Indian Penal Code.

There is enough published evidence to now label air pollution as a major potentially modifiable risk factor, not only for chronic diseases but also as a precipitating factor for death due to acute disease events such as stroke, acute heart attack, acute bronchial asthma. 

As air potentially is a potentially modifiable risk factor, any attributed to it is a preventable death. And, any preventable death should be unacceptable.

Every death, which occurs in the setting of air pollution, should be audited and accounted for. There should be a column in the death certificate, which should state if the death was attributable to air pollution. This should be a policy.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA