Govt. revises regulations for conducting clinical trials

Govt. revises regulations for conducting clinical trials

Dr K K Aggarwal
The Central Drug Standard Control Organization (CDSCO) has revised rules for conducting clinical trials in the country. · The CDSCO has done away with the earlier restriction of three clinical trials per investigator at any given period of time. The Circular File No. 12-01/14 – DC (Pt. 47) dated 2.8.16 issued by the CDSCO in this regard states: “As regards restriction that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove this restriction and it is further decided that Ethics Committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake.” · Regulations for hospitals conducting clinical trials have also been eased. In its circular File No. 12-01/14 – DC (Pt. 47) dated 3.8.16, the CDSCO said, “As regards requirement of NOC from DCGI for addition of new clinical trial site or investigator in clinical trial, it was decided in the meeting that the respective Ethics Committee after due diligence can approve proposals for addition of site(s) and investigator(s) and no NOC from DCGI in normal course, should be necessary. However, the applicant would inform DCGI about any such addition / deletion and thereafter, if no objection was received from DCGI, it would be deemed to have concurrence of CDSCO.” · A minimum number of beds is no longer a requirement for hospitals seeking to conduct a research. The CDSCO has revised this restriction vide a circular File No. 12-01/14 – DC (Pt. 47) dated 2.8.16 as follows: “As regards condition that no clinical trial shall be conducted at site having less than 50 bedded hospital, it has been decided to revise this condition and it is further decided that Ethics Committee shall examine and decide whether the clinical trial site is suitable for trial or not irrespective of number of bed. However, it was also suggested that site shall have emergency rescue and care arrangements along with all other necessary facilities required for that particular clinical trial.” (Source: CDSCO)

Do not ignore 2nd attack of dengue

Do not ignore 2nd attack of dengue New Delhi, August 03, 2016: If you have suffered from dengue in the past be more careful as the second attack of dengue may be more dangerous than the first attack, said Padma Shri Awardee Dr KK Aggarwal – President Heart Care Foundation of India (HCFI) and Honorary Secretary General IMA. There are four different strains of dengue and one can, suffer with dengue four times during lifetime. Subsequent dengue infections are more likely to end up with deadly complications. A person with dengue can also simultaneously suffer from malaria. Malaria and dengue together can lower platelet counts to a dangerous level leading to complications. In a dengue season nobody should take aspirin for fever as it can precipitate bleeding, he added. In dengue most complications occur within two days of subsiding of fever and most people are careless during this period. Any abdominal pain, giddiness or weakness after the fever has subsided should be attended to, by a doctor. Dengue complications during this period are due to shift of blood volume and patient requires rapid infusion of oral or intravenous fluids in large quantity. There is no need for giving platelets unless the counts have fallen lower than 2% of original platelet counts

Updated clinical practice guidelines for rheumatologic manifestations of Sjögren's syndrome

Updated clinical practice guidelines for rheumatologic manifestations of Sjögren's syndrome

Dr K K Aggarwal The first Clinical Practice Guidelines (CPG) from Sjögren's Syndrome Foundation (SSF) are published online July 7, 2016 in the journal Arthritis Care & Research. Physicians are advised to use nonpharmacologic approaches such as exercise to reduce fatigue in patients with primary Sjögren's syndrome. Pharmacologic therapy should be initiated with the drugs having the lowest potential for adverse effects and then escalated according to clinical response. The guidelines include a decision tree for the use of oral disease-modifying antirheumatic drugs (DMARDs) for inflammatory musculoskeletal pain beginning with hydroxychloroquine (HCQ) and progressing to methotrexate (MTX), then HCQ + MTX, then short-term corticosteroids, then long-term (>1 month) corticosteroids. Use of tumor necrosis factor-α (TNFα) inhibitors for sicca symptoms is strongly discouraged, but they can be considered in patients who also have rheumatoid arthritis (RA) or related conditions. Rituximab can be considered for treating keratoconjunctivitis sicca in primary Sjögren's inadequately controlled by conventional therapies or for xerostomia in patients with primary Sjögren's who have some residual salivary production and significant evidence of oral damage

What not to do in snake poisoning

What not to do in snake poisoning New Delhi, August 02, 2016: In the monsoon season, snake bites are common. Most of these bites are by non–poisonous snakes. In a country like India, most people are misled by Bollywood movies showing a typical scene where the hero saves the heroine by giving an incision and then he sucks the poison and spits it out. "This is what should not be done", said Padma Shri Awardee Dr KK Aggarwal – President Heart Care Foundation of India (HCFI) and Honorary Secretary General IMA. Dr. Aggarwal said that methods such as incision, oral sucking, mechanical sucking devices, cryotherapy, surgery and electric shock therapies have been widely used but are medically not recommended. A common misconception depicted in the movies is that one should apply tourniquet, suck out the poison and spit it out. Medically, this approach is strongly discouraged as it can damage the nerves, tendons, blood vessels and lead to infections. Venom removed by suction is minimal and clinically does not prevent snake bite complications. Many studies have shown that mechanical suction device reduces the total body venom burden by only 2%. First aid involves removing the patient from the vicinity of the snake. Keep the patient warm, rested and reassured. The wound should be cleaned with soap and water. One should not give drugs and alcohol as it may confound with clinical assessment. Efforts should be made to identify the snake and the patient should be transported to the nearest medical facility as quickly as possible.

New consensus statement discourages contralateral prophylactic mastectomy

New consensus statement discourages contralateral prophylactic mastectomy Women diagnosed with breast cancer who are at average risk should be discouraged from undergoing a contralateral prophylactic mastectomy (CPM), because the majority of women will obtain no oncologic benefit, says a new consensus statement from the American Society of Breast Surgeons (ASBrS). The first part of the statement outlines the effect that CPM has on relevant clinical outcomes and which patients might be appropriate candidates for CPM. While, the second part focuses on issues such as how patients feel about CPM. Key recommendations from the position paper are: • Sentinel lymph node surgery on the CPM side should not be routinely performed • CPM is a cost-effective strategy for women with BRCA mutations. At this time, there is insufficient evidence to support the concept of superior cost effectiveness for CPM in women with sporadic breast cancer and the cost effectiveness is highly dependent on the quality of life assumptions. • Women should be counseled on the potential long-term outcomes of CPM on body image and sexuality. • Shared decision making that includes a comprehensive discussion of risks and benefits of CPM is important. • CPM counseling should include discussion of CPM, risks of CPM, rates of CBC, and ensure patients are engaged in the decision making, and making decisions that are concordant with their treatment preferences and personal values The position statements are published online July 28, 2016 in the Annals of Surgical Oncology. (Source: Medscape)

Preventing electrical deaths in the monsoon season

Preventing electrical deaths in the monsoon season Do not use 2 pin electrical appliances as they can be dangerous New Delhi, August 01, 2016: In countries like India where 2–pin electrical appliances are still used, it is common to see a few people dying every day due to electrocution in major cities. Most of these deaths are preventable, said Padma Shri Awardee Dr KK Aggarwal – President Heart Care Foundation of India (HCFI) and Honorary Secretary General IMA. Even if an electrical death occurs an electrocuted dead body can be revived within 10 minutes by using the conventional principles of cardiopulmonary resuscitation using the Formula of 10 where within 10 minutes of cardiac death for the next 10 minutes, compress the heart of that person at a speed of 100 per minute. Obviously, first the electrical source needs to be disconnected. Most deaths in India are due to misuse of earthing. In India, earthing can be procured either from the city source or made indigenously at home by digging a deep hole in the earth.’ Follow these Dos and Don’ts about earthing to prevent electrocution deaths: 1. Earthing is a thick wire attached to the top hole of a 3–pin electrical socket. 2. In any electrical circuit, green wire is for earthing, black for neutral and red for live wire. Earthing lead by convention is kept green so that it can be identified easily. 3. Normal electricity is generated when the live wire is connected to the neutral wire. Live with earth wire will also give the electrical current. There will be no current when the earth wire is connected to the neutral wire. 4. Earthing is a safety outlet, which allows leaking electricity to be conducted away harmlessly and not through the body. 5. Earthing needs to be checked every 6 months because it deteriorates with time and weather, particularly during the rainy season. A check can be carried out using an ordinary tester on the body of the appliance. 6. A test lamp can also check that earthing is proper. One can light bulb with live and earth wire. If the bulb fails to light while connecting live and earth socket it means the earthing is defective. 7. People tend to take earthing lightly and often misuse it. 8. Live and earth wires are sometimes untied together for temporary connection, which can be dangerous to life. Following are the general precautions, which people should take to prevent electrical hazards: 1. Make sure that you have proper earthing connection in the house. 2. Always remember the green wire, without it, do not use any electrical appliances especially if it is touching any water surface. Water enhances conductivity; extra precautions therefore should be taken, while handling appliances, under wet conditions. 3. 2–pin plugs with no earthing arrangements should not be used and in fact should be banned. 4. While using 3–pin plugs, make sure all 3 wires are connected and the pins are not defective. 5. Do not use matchsticks to hold wires in the socket. 6. Do not touch any wire without ensuring that power supply is switched off. 7. Do not use the earth wire to replace the neutral wire. 8. All joint wires should be properly insulated with proper insulated tapes and not with sellotape or Band–Aids. 9. Before using geyser water, it should be switched off. 10. Do not use heater plates with exposed wire for cooking purpose. 11. Use dry rubber slipper at home. 12. Use mini circuit breaker (MCB) and earth leak circuit breaker (ELCB) facilities at home. 13. Metallic electrical appliance should not be kept near a water tap. 14. Using rubber mats and rubber leggings in the desert cooler stand can insulate electrical appliance. 15. Use only recommended resistance wires and fuses. 16. Earthing should be checked every 6 months. 17. Any ordinary tester can check the presence of leaking electricity. 18. Wrap cloth around the handle of the refrigerator 19. Read the set of instructions attached with every electrical appliance. 20. Accidental electric deaths occur more often in India due to the use of 220 V than in the US, where 110V is used. 21. AC current is more dangerous than DC. An AC current of more than 10 MA causes tetanic muscular contractions making it impossible for a hand grasping an energized object, to free itself. In case of electrocution, proper resuscitation is necessary. The mains should be switched off or wires disconnected using a wooden material and cardiopulmonary resuscitation should be started immediately. In a clinically dead patient, a thump in the center of the chest from a distance of one foot may alone revive a person. In severe electrocution, clinical deaths occur within 4–5 min., therefore time to act is limited. Do not wait for the victim to be taken to the hospital. Act there and then.

IMA hails PM taking up the cause of medical profession

IMA hails PM taking up the cause of medical profession

Dr K K Aggarwal PM Modi initiates health campaign and asks people to avoid taking antibiotics without the doctor’s prescription In his monthly address to the people of the nation in ‘Mann Ki Baat’, Prime Minister Shri Narendra Modi urged people to not take antibiotics without the prescription of a doctor since resorting to such short cuts to get better soon has been giving rise to new problems. He also asked the citizens to take antibiotics for the entire course prescribed by the doctors and not leave it midway as it can potentially lead to antibiotic resistance. He informed the people that the Government is resolute on stopping the menace of antibiotic resistance and that antibiotic medicine strips are now having a red line to warn the people. He suggested that in order to get well soon, consuming any antibiotic that is available easily, without consulting a doctor, is not a wise choice. While explaining the issue of antibiotic resistance, he stated that random and excessive use of antibiotics makes the causative organisms accustomed to the particular drug, and the drug thus loses its efficacy and utility. This practice of impetuous use of antibiotics thus creates newer problems that require years of research to find out solutions for. Additionally, leaving an antibiotic course, prescribed by a doctor, midway, or continuing it for longer than prescribed, both will harm the patient and help the bacteria. The causative organisms are fast undergoing mutations and rendering the once-effective antibiotics, ineffective now, thus adding to the problem of antibiotic resistance. While antibiotic resistance is a global public health problem, the issue nowhere is it as stark as in India. Resistance to fluoroquinolones among invasive Salmonella Typhi isolates in India was 8% in 2008 that rose to 28% in 2014. And antibiotic use itself is the most significant driving force behind this resistance. In the year 2010, India was the world’s largest consumer of antibiotics for human health, with consumption estimated at 12.9 x 109 units (10.7 units per person). It is high time that we start taking our health seriously and understand that the use of antibiotics without prescription is going to do more harm than good.