PSM News

May 03,2024 London: U.S. attorneys for a woman who claims her colon cancer was caused by the now discontinued heartburn drug Zantac on Thursday told a jury in Chicago that pharmaceutical companies GSK and Boehringer Ingelheim knew the product could cause cancer if it was not handled properly but failed to warn the public. Mikal Watts, who is representing 89-year-old Angela Valadez, said the companies knew that Zantac’s active ingredient, ranitidine, would turn into a cancer-causing substance called NDMA as it aged or was exposed to extreme temperatures, but did not ensure it was properly handled by transporters, distributors and stores. Valadez’s case is one of tens of thousands against GSK, Boehringer Ingelheim and other pharmaceutical companies, which have worried investors in recent years. It will offer the first test of whether the cancer claims in the long-running litigation will persuade a jury, since all cases previously set for trial settled or were dropped. GSK and Boehringer Ingelheim are the only defendants in the trial, after other companies settled. Watts told the jury the pills would change color as they degraded, but the companies would cover it up. “They know we’re not going to take a product that looks bad, so they put a paint job on it,” Watts said. Attorneys for GSK, which developed the active ingredient in Zantac but later sold the brand to other companies, and Boehringer Ingelheim, which sold the drug from 2006 until 2017, countered that Zantac has been repeatedly proven to be safe and effective and that no scientific or medical study had connected Zantac to cancer. There is “no objective evidence linking Ms. Valadez’s cancer to Zantac,” GSK’s attorney Tarek Ismail told the jury. “No genetic test, lab report, imaging study… nothing whatsoever.” Valadez, who said she took Zantac every day for at least 18 years, had a host of risk factors that made her more likely to develop colon cancer, Ismail said. First approved in 1983, Zantac became the world’s best selling medicine in 1988 and one of the first-ever drugs to top $1 billion in annual sales. It was originally marketed by a forerunner of GSK and later sold successively to other companies. In 2020, the U.S. Food and Drug Administration asked drugmakers to pull Zantac and its generic versions off the market after NDMA was found in samples of the drug. Thousands of lawsuits began piling up in federal and state courts. A new version of Zantac now on the market has a different active ingredient and does not contain ranitidine. Source: Pharma

May 03,2024 New Delhi: A top Indian medical scientist has asked people not to panic as any side effect of a COVID-19 vaccine is a “rare occurrence”. Former Indian Council of Medical Research (ICMR) scientist R Ganga Ketkar, who was at the helm of affairs during the COVID pandemic, said symptoms of Thrombosis with Thrombocytopenia Syndrome (TTS) – a serious adverse event that causes blood clots – can only occur within five to 30 days of receiving a COVID vaccine and not now. This comes as British pharmaceutical major AstraZeneca, which developed Covishield vaccine along with the University of Oxford, has admitted that the vaccine can cause a rare side effect. “The benefits of the vaccine outweigh the risks,” Ketkar told ET. “People should not worry as the number of cases are pretty small and TTS develops within 5-30 days after receiving the vaccine and not now.” He said as the number of doses increases, the risk of TTS goes down. “There is no reason to worry at this point in time,” Ketkar added. He said that vaccine developers continue post marketing surveillance, which means that they monitor the safety of vaccines once they reach the market. “One thing people should remember is that whether it is a medicine or vaccine, there will be a rare occurrence of diseases, but one will have to look at the benefits,” he said. AstraZeneca is facing class action suits in the UK over allegations that the vaccine caused death and serious injury, including TTS that causes blood clots and a low blood platelet count. In India, Serum Institute of India manufactured the Covishield vaccine under licence from AstraZeneca. Ketkar said there is a need to clear out myths. “If people worry, they tend to google and get influenced. It is possible if they think in a negative light, childhood vaccination will be hit.” He said that unnecessary “unscientific” messages can only spread further panic in the society, and that should be stopped. According to reports, AstraZeneca has admitted in a legal document that its COVID vaccine “can, in very rare cases, cause TTS”. “In India, Covishield, which was used to vaccinate 90 per cent of India’s population, has done well,” a senior person from the COVID working group told ET, playing down concerns of adverse events, despite the rare risk of TTS. Source: Pharma

May 05,2024 Guwahati: A study conducted by physician-scientists from Assam Medical College Hospital (Dibrugarh), supported by ICMR-recognised multidisciplinary research laboratory, has revealed that 55 per cent of Covishield vaccine recipients experienced only minor side effects like fever and headache. These symptoms occurred within a week of getting inoculated with the first dose. Researchers confirmed no long-term adverse effects after a year. “In our study, we found that 55 per cent experienced minor adverse events such as fever, headache, body ache and pain at the injection site. The remaining 45 per cent of the recipients had no adverse events at all. After the second dose, only 6.8 per cent showed minor adverse events following immunisation (AEFI). Most importantly, no participant showed any major adverse events during the entire one year period of study,” said associate professor of pathology at AMCH, Gayatri Gogoi, the principal investigator of the study done in Assam’s Dibrugarh district. The major (serious and severe) adverse events were defined as disabling, rare life-threatening conditions that may lead to long-term problems. “The young individuals had more minor adverse events than the elderly individuals. What is also intriguing to note is that those who had comorbidities or other health conditions showed less adverse events,” she added. The study was conducted from July 2021 when the first Covishield vaccine for the public was introduced and participants were followed up till June 2022 after receiving the approval of the Institutional Ethics Committee to conduct the same. This data of research findings was recently accepted for publication in a well-known PubMed indexed journal named Journal of Family Medicine and Primary Care. The doctor-research investigators felt the need of sharing the real-time research data from Dibrugarh district, led by Gayatri Gogoi, who is also a renowned cancer researcher, along with Dr Gourangie Gogoi, professor of community medicine at AMCH, Dr Bhupendra Narayan Mahanta, professor of medicine (currently posted at Lakhimpur Medical College Hospital) and Dr Mithu Medhi, professor of microbiology (currently posted at Kokrajhar Medical College Hospital) after completing a study on Covishield vaccine effectiveness and AEFI or side effects. The study design was done in consultation with Dr Biswajyoti Borkakoty, head of Regional Viral Research & Diagnostic Laboratory, Regional Medical Research Centre-NE Region (ICMR), Dibrugarh as nodal officer from this region for the pandemic time. The researchers said during the peak of the Delta variant wave in June 2021, it was found that 61 per cent of the participants had been infected with the SARS-CoV-2 virus. The remaining 39 per cent were sero-negative, meaning they had not contracted the virus and had received the Covishield vaccine. Regarding the effectiveness or antibody development, 93 per cent remained positive and the antibody level was much higher in case of the vaccinated. Among those participants previously infected by SARS-CoV-2 virus, the first dose of Covishield vaccine acted as booster dose and was enough to enhance high rise of antibody titre in contrast to SARS-CoV-2 uninfected participants. “The final inference was that natural virus infections confer stronger immune responses than Covishield vaccine alone,” said Gogoi. Source: Healthworld

May 10,2024 New Delhi: Soaring temperatures in many parts of India are fuelling demand for medications that manage chronic conditions. This includes medications for high blood pressure (antihypertensives), cholesterol (lipid-lowering drugs), and blood clotting (platelet aggregation inhibitors). Sales of oral electrolytes and sunscreens are also seeing a surge, according to market researcher Pharmarack. Industry data shows sales of antihypertensive drugs have risen to ₹1,134 crore in April from ₹1,129 crore in March and ₹1,119 crore in February. It recorded ₹13,468 crore in Moving Annual Turnover (MAT) in the 12 months through April 2024. Likewise, sales of lipid-lowering drugs rose from ₹520 crore in February to ₹541 crore in April. Hot and humid weather in various parts of the country is pushing sales of platelet aggregation inhibitors, which work in different places of the clotting cascade and prevent platelet adhesion. Sales of such drugs increased from ₹112 crore in February to ₹114 crore in April. Recent heatwave episodes across the Indian landscape may have led to discomfort in the vulnerable population causing a surge in demand for chronic therapies like antihypertensives, lipid-lowering drugs, and platelet aggregation inhibitors,” Sheetal Sapale, vice president, commercial, Pharmarack told ET. Meanwhile, rising temperatures and the need for hydration management is triggering a twofold increase in oral electrolyte consumption this year. “The concerted efforts of pharmaceutical companies in conducting awareness campaigns have yielded promising results, fostering a proactive approach towards health consciousness among the populace. This push has resulted in a significant double-fold multiplication in oral electrolytes consumption over the past five years, particularly in response to rising temperatures and the need for hydration management,” Sapale said. With prevailing high temperatures, the cosmo derma segment also saw an uptick in both value and unit consumption. In April, buoyed by escalating skincare preferences among consumers, segments such as emollients, protectives, and sunscreens experienced steady growth, as per Pharmarack. Overall, in April, the Indian Pharmaceutical Market(IPM) showed robust growth, reaching a notable value of ₹16,413 crore, marking a 9.2% increase in value compared to a year earlier. On a MAT basis, the IPM demonstrated its resilience, reaching ₹1,99,288 crore with a value growth of 7.3%. Source: Pharma

May 10,2024 New Delhi: In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India. At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible. “The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as ‘safe and effective’, without scientific investigation and invoking epidemiology,” Dr Tarun Kothari, a radiologist and an activist, said at the press conference. The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said. When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist. There is an already low awareness around vaccine injuries, especially in India, she said. Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added. “The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination,” Dr Kothari said. The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well. “We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families,” Dr Mittal said. Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated. “Review science behind all Covid vaccines and audit their commercialisation,” Dr Kothari said. The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as ‘Covishield’ in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts. The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement. In India, the company’s partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021. AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe. Source: Healthworld

May 06,2024 New Delhi: COVID is still there among us and recently two new variants have been found in the US. Termed as the “FLiRT” these two variants include KP.2 which overtook the JN.1 subvariant of Omicron in recent weeks. As per the latest data from the U.S. Centers for Disease Control and Prevention, KP.2 is behind one in four infections nationwide. The other FLiRT variant is KP.1.1 which is also circulating in the US but is less widespread than KP.2. It currently accounts for about 7.5 per cent of infections nationwide, per the CDC. Why the name FLiRT? According to the Infectious Disease Society of America, the nickname ‘FLiRT’ is based on the technical names for their mutations. The World Health Organisation (WHO) has reclassified it as a variant of interest and advised close monitoring. The FLiRT variants are spinoffs of JN.1.11.1. They are a part of the Omicron variant. New COVID variant FLiRT symptoms The symptoms of the new variant are similar to those of other Omicron subvariants, such as sore throat, cough, fatigue, nasal congestion, runny nose, headache, muscle aches, fever, and possible loss of taste and smell, experts have said. “The KP.2 variant (also called JN.1.11.1.2) is a descendant of the JN.1 variant and contains several mutations that are associated with escape from vaccine-mediated immune protection. Preliminary research (not yet peer-reviewed) suggests that the estimated relative effective reproduction number of KP.2 (Re) may be 1.22 times higher than the Re for JN.1,” Infectious Disease Society of America has said in a report. FLiRT, which belongs to Omicron’s JN.1 lineage, is rapidly replacing the previous variant, Eris, in the US, the UK, New Zealand, and South Korea, according to Rajeev Gupta, Director of Internal Medicine at the CK Birla Hospital (R), Delhi. “A recent increase in hospitalisation rates in these countries has been attributed to this variant; however, it has remained a relatively small wave. The overall mortality rate has not increased,” he told news agency IANS. “Fortunately, none of the Omicron lineage is able to induce significant lung damage as delta strain did but limited to the upper respiratory tract. The surveillance and vigilance should be kept for major drift in virus,” Dhiren Gupta, a Pediatric Intensivist at Sir Ganga Ram Hospital told IANS and added that these new strains will keep emerging. COVID-19 preventive measures include practicing good hand hygiene by washing hands frequently with soap and water or using hand sanitizer, wearing masks in crowded or indoor settings, maintaining physical distance from others, avoiding large gatherings, and staying home when feeling unwell. Vaccination against COVID-19 is strongly recommended to reduce the risk of infection, severe illness, and transmission. Additionally, following public health guidelines, such as ventilation in indoor spaces and regular testing, can help mitigate the spread of the virus. Combining these measures provides a comprehensive approach to protecting oneself and others from COVID-19. Source: Healthworld

May 09,2024 New Delhi: Amid concerns over thrombosis with thrombocytopenia syndrome (TTS) – a serious adverse event that causes blood clots and a low blood platelet count, linked to AstraZeneca’s Covid vaccine – Serum Institute of India (SII), the maker of the product in India, said that it had disclosed all information about the side-effects in its packaging insert in 2021 itself. Safety of vaccines remained “paramount”, a SII spokesperson said on Wednesday. However, a group of parents who lost their children to alleged adverse effects after taking Covishield, believes the number of deaths or serious injury could be much more in India than the government figures even as more parents join in to fight it out in the court. According to reports, AstraZeneca has admitted in a legal document that its Covid vaccine “can, in very rare cases, cause TTS.” “The number of people who have died due to TTS and other causes from vaccine could be much more than the official figures. A lot of people have got in touch with us and will join the fight,” said Venugopalan Govindan, whose 20-year-old daughter, Karunya, died allegedly from complications related to vaccination. Govindan said the AEFI system is inaccessible to common man to even file an adverse report. “The adverse event facility incorporated in COWIN portal after the judgement in Jacob Puliyel case is not functional most of the time, and when it works, it just takes the entry, and we don’t ever hear back about it,” he said. Govindan said that there is no accountability to study and publish causality within a certain timeframe (adverse events suffered in 2015 are decided in 2023). “Data is consciously not made available in an analysable way.” The parents are in touch with lawyers and discussing their case as they contemplate filing a case against its manufacturer, Serum Institute of India (SII). AstraZeneca is facing class action suits in the UK over allegations that the vaccine caused death and serious injury, including thrombosis with thrombocytopenia syndrome (TTS). “Many new families have got in touch and will join in the fight,” Govindan added. A senior member of the Covid working group said that the group finished the assessment related to adverse events in 2022 and the number of people dying due to TTS are “extremely low.” A few of these parents had earlier approached court blaming administration of the Covid vaccine for the death of their children. The petition was mainly against the government and the authorities that cleared the vaccines for administration allegedly without proper studies, and SII was not a party in those cases. After AstraZeneca’s admission surfaced, the parents are now hopeful of justice. “As responsible manufacturers, AstraZeneca and SII should have stopped the manufacturing and supply of these vaccines when 15 European countries either suspended or age-limited these vaccines due to the deaths from blood clots that happened in 2021 March, within a couple of months of the rollout of the vaccine,” he told ET. Source: Pharma

Apr 27,2024 New Delhi: The ICMR has planned to expand its Indian Clinical Trial and Education Network (INTENT) and invited tenders from public and private medical research institutes for coordinating regulatory clinical trials for drugs and devices. These expressions of interest would help in the growth of the national network, which encompasses 47 institutes that include public and private medical colleges, hospitals, and research institutes including the ICMR institutes. The ICMR established INTENT, a network of medical colleges and research institutes, with an overarching goal of providing evidence-based, and culturally sensitive solutions to health issues of national priorities by conducting large, decisive, regulation compliant clinical trials. This network is invested in providing an end-to-end solution for clinical trials for the Indian researchers. “The ICMR now plans to expand the national network and accordingly invites expressions of interest (EOI) from public and private medical research institutes in India to contribute to the INTENT activities,” an official document said. The broad objectives of the network are to generate high quality evidence by conducting and coordinating hospital-based and community-based trials in the diseases or health conditions of public health importance in India. The aim is also to guide health policies and informed management practices based on the evidence generated and build capacity of clinical researchers in India for the planning, conduct, analysis and scientific dissemination of the clinical trials, the document stated. The INTENT proposes to co-ordinate regulatory clinical trials or clinical investigations for drugs, devices, vaccines, biologics developed or co-developed with academia, start-ups or industry that address the national health priorities. Additionally, trials that are planned through inter-ministerial collaborations may also be conducted by INTENT. The INTENT is being coordinated by Clinical Studies and Trials Unit (CSTU) under Division of Development Research at ICMR, Delhi. The selected centres from the EOI applicants will have the privilege of first preference as sites in case of trials conducted under the ambit of INTENT. Source: Healthworld

Apr 24,2024 Hyderabad: Some medical shops were found to be selling certain anti-fungal medicines at almost double the actual cost, the Drugs Control Administration (DCA) said. Stocks worth 5.5 lakh were seized during two separate raids conducted on Tuesday. DCA officials seized two medicines from shops in Vanasthalipuram and Hayathnagar mandal of Rangareddy district, which were being sold at much higher prices than the central government fixed price. The medicines — Itrazole 100 and Itrazole 200 — are commonly used to treat fungal infections. The drugs were manufactured by Sunfine Health Care in Solan, Himachal Pradesh, and marketed by a company in Haryana. Officials said that Itrazole 200 was being sold at 43 per tablet instead of the actual price of 24 per tablet. Similarly, Itrazole 100 was being sold at 31 per tablet instead of 18, which means a patient has to cough up an extra 100-150 for a strip of ten tablets. “Selling overpriced medicines is not only illegal, but it also means that healthcare is inaccessible to many,” the DCA said, adding that strict action would be taken against offenders. Hyderabad: Some medical shops were found to be selling certain anti-fungal medicines at almost double the actual cost, the Drugs Control Administration (DCA) said. Stocks worth 5.5 lakh were seized during two separate raids conducted on Tuesday. DCA officials seized two medicines from shops in Vanasthalipuram and Hayathnagar mandal of Rangareddy district, which were being sold at much higher prices than the central government fixed price. The medicines — Itrazole 100 and Itrazole 200 — are commonly used to treat fungal infections. The drugs were manufactured by Sunfine Health Care in Solan, Himachal Pradesh, and marketed by a company in Haryana. Officials said that Itrazole 200 was being sold at 43 per tablet instead of the actual price of 24 per tablet. Similarly, Itrazole 100 was being sold at 31 per tablet instead of 18, which means a patient has to cough up an extra 100-150 for a strip of ten tablets. “Selling overpriced medicines is not only illegal, but it also means that healthcare is inaccessible to many,” the DCA said, adding that strict action would be taken against offenders. Source: TOI

Apr 20,2024 London: The World Health Organisation is likely to issue a wider warning about contaminated Johnson and Johnson-made children’s cough syrup found in Nigeria last week, it said in an email. Nigeria’s regulator recalled a batch of Benylin paediatric syrup last Wednesday, having found a high level of diethylene glycol in the product during routine testing. The contaminant, alongside another closely related toxin, ethylene glycol, has been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan since 2022, though there is no evidence that these incidents are linked with the latest recalls. The U.N. health body said it puts out global medical product alerts to “encourage diligence” by national authorities and was likely to do so in this instance, “subject to confirmation of certain details from parties”. The recalled batch of Benylin syrup was made by J&J in South Africa in May 2021, although Kenvue now owns the brand after a spin-off from J&J last year. J&J has referred requests for comment to Kenvue. In an emailed statement on Friday, Kenvue said it had carried out tests on the batch recalled by Nigeria and had not detected either diethylene or ethylene glycol. “We continue to work closely with health authorities and the WHO and are engaging with NAFDAC to understand their test results, including verifying the authenticity of the sampled product, the testing methodology used, and results reported by the agency,” the statement added. Since Nigeria’s recall, five other African countries have also pulled the product from shelves – Kenya, Rwanda, Tanzania, Zimbabwe and South Africa, where the drug was made. South Africa’s regulator has also recalled another batch of the syrup, which is used to treat coughs, hay fever and other allergic reactions in children. Diethylene glycol is toxic to humans when consumed and can result in acute kidney failure, although there have been no reports of harm in the latest incident. In the 2022 cases, the contamination in the syrups came from the raw materials used by manufacturers in India and Indonesia. The WHO said it was collaborating with both the manufacturer and regulatory authority in South Africa to investigate the Benylin paediatric syrup, and had information on the source of the ingredients used. Kenvue has previously said it tested its ingredients before manufacture. The agency said the possibility that the syrup was counterfeit was also “under consideration as part of investigations”. Earlier this week the WHO sent out a separate alert on five batches of contaminated cough syrup ingredients found in Pakistan that appeared to have been falsely labelled as Dow Chemical products. It was the first alert the WHO has sent on excipients – elements of a medicine other than the active pharmaceutical ingredient – rather than finished products, the agency confirmed on Friday. The batches of propylene glycol were contaminated with ethylene glycol. Source: Pharma