My Clinical Trials Diary

With researchers finding in a trial involving 10,000 adults that an existing anti-inflammatory drug has the potential to lower lung cancer risk, doctors in India have expressed hope for better tackling of the critical disease. According to a study published in the journal Lancet, death from cancer was reduced by half in a group of people who received the highest dosage of the drug known as Canakinumab and also led to 67 per cent reduction in lung cancer incidence. Canakinumab was found to lower inflammation, without affecting cholesterol level — which was the widely used approach for many years. It was also found effective against heart attack, stroke and cardiovascular death. "As a rule, anti-inflammatory drugs have a role in prevention of cancer. With the rise in pollution levels across the country, there will be added burden on the lungs of those who may be suffering for lung cancer," Dinesh Katiyar, Senior Consultant (Surgical Oncologist) at Venkateshwar Hospital here, to...

​ Thanks to ancient science Ayurveda which came up with a unique wonder drug under the name of S.Compound. Work on herb was started in the year 1974 and ultimately it was confirmed that the herb has great potential in inflammatory conditions. However, its role on arthritis was explored because it was the most neglected disease by the scientists and Medical fraternity. The available pain killers were causing huge harm to our body systems and some of the available pain killers were even banned in Europe. The herbal medicine S.Compound was compared with Phenylbutazone by the scientists of Central Drug Research Institute Lucknow in the year 1983 and was found better in efficacy Controlled Clinical trials were carried out on human beings suffering from Rheumatoid arthritis; Is not only its efficacy was confirmed but it was also found safe in long duration. The research work was published in Eastern Pharmacist which was reported by country's premier News Agency United News of India on 21...

A research team at the University of Nebraska Medical Center College of Public Health has determined that a special mixture of good bacteria in the body reduced the incidence of sepsis in infants in India by 40 percent at a cost of only $1 per infant. The findings are reported in the Aug. 16 issue of the journal Nature. Pinaki Panigrahi, M.D., Ph.D., professor, epidemiology and pediatrics, Center for Global Health and Development, and his colleagues in the College of Public Health, led the international research team. The results reflect a culmination of 15 years of research and could seriously impact infant health worldwide. The special mixture included a probiotic called Lactobacillus plantarum ATCC-202195 combined with fructo-oligosaccharide (FOS), an oral synbiotic preparation developed by Dr. Panigrahi. Probiotics are live bacteria and yeasts that are good for your health, especially your digestive system. Synbiotics are combinations of probiotics with an FOS supplement that promo...

Doctors have urged caution against the use of two medications widely prescribed for chronic low back pain after a systematic review of medical evidence found they carry significant risks of adverse effects without any proven benefit. The available evidence does not support the use of gabapentin and pregabalin for treating chronic low back pain, the doctors based in Canada and India said after reviewing multiple earlier studies comparing these drugs with placebo treatment, or sham pills. Chronic low back pain is a common health disorder with studies indicating prevalence rates of four in every 100 persons between 24 and 39 years to 20 in every 100 persons between 20 and 59 years. Doctors typically use non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics to treat acute low back pain. But patients with chronic low back pain often receive prescriptions for gabapentin or pregabalin, which have been shown to be helpful in treating nerve-linked pain. "There is no justification f...

A national research institute of 'Unani' medicine will be set up at a village in Faridabad district, a spokesman of Haryana government said today. The institute, which will provide healthcare facilities in the field of non-communicable diseases, would also include a 120-bedded in-patient department, the spokesman of the Ayush department said. Chief Minister Manohar Lal Khattar has approved a proposal to allot land of Kheri Gujran village for the institute. The institute would be developed as a state-of-the-art research centre with facilities for pre-clinical studies, clinical trials, drug standardisation and cultivation of medicinal plants used in 'Unani' system, the spokesman said. It would also offer facilities such as research and geriatric OPDs, speciality clinics, he said. The institute would have laboratories for bio-chemistry, pathology, radiology and USG, drug standardisation, immunology, pharmacognocy and phytochemistry, besides regimental therapy unit, library...

Some medically useful compounds of cannabis may open the door for medical marijuana in India through a new government policy IN India, the controversial cannabis plant is a league of its own in legal, cultural, and religious spheres. A video on Swami Ramdev's YouTube channel about medical use of Indian hemp by Acharya Bal Krishan, CEO of Patanjali, underlines its scope in ayurveda. Even though the Narcotic Drugs and Psychotropic Substances Act banned the production and sale of cannabis resin and flowers, it left the leaves and seeds for the states to regulate. For all you know, medical marijuana may already have made its way into India. Ram Vishawakarma, director of CSIR-India Institute of Integrative Medicine in Jammu, uses the word cannabidiol (CBD) instead of medical marijuana. At the institute, he is conducting a research on medical uses of CBD, an extract from the cannabis plant. Quoting studies published in top medical journals such as Nature, Vishawakarma says CBD has been a...

While cholera vaccines work quite well for adults, they provide significantly less protection for children under 5, a population particularly at risk for dying from this diarroheal disease, says a study based on a review of research literature. The review, which considered seven clinical trials and six observational studies, found that the standard two-dose vaccine regimen reduced the risk of getting cholera on average by 58 per cent for adults but only by 30 per cent for children under age 5. The findings, published online in the journal The Lancet Infectious Diseases, could help inform policymakers on how and when to use the vaccine, particularly in outbreak settings such as the ongoing epidemic in Yemen, which has seen an estimated 400,000 suspected cases and as many as 1,900 associated deaths since the outbreak began in April 2017. Cholera is transmitted through an oral-fecal route, with outbreaks and endemic transmission tending to occur in areas with poor sanitation and a lack of...

Mylan's anti-Tuberculosis drug Delamanid's treatment will be limited to those patients who have stopped responding to most of first and second line of treatment. Indian unit of US drug maker Mylan Inc. has received approval from the country's drug regulator DCGI to market Delamanid, a new class of anti Tuberculosis (TB) medicine discovered to specifically treat Multi Drug Resistant TB (MDR) in India. Like Bedaquiline, which was the first TB drug launched in 40 years in 2016, Delamanid's treatment will be "limited" to those patients who have stopped responding to most of first and second line of treatment. The drug billed as "wonder drug" will be rolled out in government-run-TB programme. Prior to this, the ministry of health and family welfare had in 2016 launched Bedaquiline drug for treatment of drug resistant TB for 600 patients across India. It was made available in five cities-Delhi, Chennai, Mumbai, Guwahati and Ahmedabad. With cases of multi d...

The Union health ministry is reported to be considering to do away with the mandatory three phase clinical trials before launching new drugs if they have proved their safety and efficacy in developed countries. For this exemption, these new drugs should have been approved and marketed for at least two years in the markets of European Union, UK, US, Australia, Canada and Japan. The health ministry already sent the draft proposal in this regard to the ministry of law and justice for clearance. Permission to market new drugs are usually granted by the regulatory authorities in any country including in India only after carefully assessing the adverse drug reactions during the clinical trials.  The health ministry thinks that the decision can avoid unnecessary repetition of trials and speed up the introduction of new drugs in the country. The health ministry thinks that change in trial rules should make it easier for the pharmaceutical companies to introduce drugs in India which are already...

The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter's India correspondent. In a parallel move, the Health Ministry is also preparing a framework for public private partnership to tackle the menace of non-communicable diseases in the country, In a move that could potentially result in affordable Medicare and health security moving to a larger section of the population, the government is considering a rash of policy measures in favor of poor patients. Talks are also on in government circles to abolish clinical trials on proven drugs that have been approved and marketed for at least two years in the European Union, United States, UK, Australia, Canada and Japan. A draft proposal in this regard has been prepared by the Health Ministry. If instituted, it would reduce the time taken to introduce n...

For the first time, genetically modified human embryos have been developed in the US and Kashmir-born doctor Sanjeev Kaul has played a lead role in this breakthrough. Scientists have now demonstrated an effective way of using a gene-editing tool to correct a disease-causing gene mutation in human embryos and stop it from passing to future generations. Though this is not a full-fledged start of a revolution of having designer babies, the first steps, however, have been laid. China attempted this earlier. A team of scientists has altered human embryos using a new technique called CRISPR CAS9 that edits genes and in this case it helped remove a fatal mutation that leads to heart attacks. This now opens up an ethical Pandoras Box if germline repairs and enhancements may become a thing in vogue. As of now, the human embryos were not implanted in humans. But this now opens up exciting prospects of the world having designer babies soon. The research published in British journal Nature shows t...

The move to abolish clinical trials of proven drugs will reduce time taken to introduce new drugs in India to just 45 days from 5-6 years. In a move aimed at speeding up the availability of new drugs, the government has proposed doing away with clinical trials for drugs that have proved their efficacy in developed markets. According to a proposed new set of rules, a part of which has been reviewed by Mint, the government suggested waiving local clinical trials for drugs that have not had any major adverse effects on patients. These drugs should have been approved and marketed for at least two years in the European Union, UK, US, Australia, Canada and Japan. The ministry of health and family welfare has sent the draft proposal to the ministry of law and justice for vetting before it can be notified. The move is expected to reduce the time taken by a company to introduce new drugs in the market from 5-6 years to as few as 45 days. According to the drug regulator, the move will also lower...

Common anti-allergy medicines could prove to be an effective treatment for potentially fatal blood clots in the legs, a study has claimed. The research by the University of Birmingham in the UK could lead to new treatments that prevent deep vein thrombosis (DVT), a blood clot that develops within a deep vein in the body, usually in the leg, and causes swelling, aching and difficulty walking. It can be caused by prolonged periods of immobility, such as after surgery or during a long flight. If the clot becomes dislodged it can travel to the lungs and block a blood vessel. This is known as a pulmonary embolism (PE). An estimated 30 per cent of PEs cause sudden death. The team discovered that mice genetically depleted of mast cells, a type of immune cells, are protected from developing DVT. The current treatments for DVT include anti-clotting drugs such as heparin and warfarin. These drugs are relatively effective but put patients at increased risk of bleeding. ​Finish reading this articl...

St. Jude Children's Research Hospital recently announced that it has signed a licensing agreement granting Serum Institute of India exclusive rights to complete the development of the hospital's respiratory syncytial virus, or RSV, vaccine. Through this agreement, Serum Institute of India will be able to design and conduct clinical trials investigating the intranasal SeVRSV vaccine and commercialize the vaccine in South America, Africa and much of Asia, according to a press release. "RSV remains a serious threat to infants worldwide during their first year of life and to anyone, including pediatric cancer patients, whose immune response has been weakened by illness or age," James R. Downing, MD, president and CEO at St. Jude, said in the release. "We are pleased that Serum's staff and leadership have recognized the life-saving potential of this vaccine. We look forward to working closely with them to make this vaccine accessible around the globe." RSV is...

In an interview with ETHealthworld,  Dr Pramod K Srivastava , Prof & Director of the Centre for Immunotherapy of Cancer & Infectious Diseases, Connecticut, US, talks about the role and opportunities in genomic research and the making of cancer vaccine. You have been associated with  clinical research  right from the 90s. Tell us about the opportunities that  genomics  offers today? Around 1990's there was no genomics in cancer immunology or cancer immunotherapy. The whole idea of genomics coming into it has come about only in the last 5 or 6 years because only then could we look at the entire genome of a patient. What we can do today is to take the cancer of a patient, take their normal tissues and read the entire genome both normal and the cancerous within a week and we can compare how it is different within another week. So basically in two weeks time in surgery or from biopsy we can pinpoint all the positions where this cancer is different from the normal tissue. This ca...

The 19th round of Regional Comprehensive Economic Partnership (RCEP), a mega free trade agreement being discussed among 16 countries including India, concluded last week. However, the key issues holding the final text of these negotiations don't seem to be getting resolved. These negotiations, which started in 2012, are largely considered to be anti-farmer, anti-poor, pro-corporations, and often undermine the socio-economic growth of less developed countries. One of the worst affected commodities of RCEP will be cheaper generic medicines. The negotiations are held in utmost secrecy and without any communication to the general populace. Though the draft of RCEP negotiations has never been made public, its chapter on intellectual property was leaked in October 2015. The chapter contained some frightening provisions favouring big pharmaceutical companies. The provisions allow these companies to increase their monopoly over medicines for a longer period, shooting up their prices many t...