Sanofi under fire over its Dengue vaccine

French drugmaker Sanofi has come under fire as Philippines has suspended the company’s Dengvaxia vaccine — the first promising vaccine for dengue— amid widespread fears about its safety and growing public anger over its use in 830,000 schoolchildren, reports The New York Times. Dengue is a disease spread by mosquitoes that infects about 400 million people worldwide. It puts 500,000 people in the hospital each year and kills 25,000, mostly in Latin America and South Asia. 

“The newly revealed evidence, confirmed recently by Sanofi’s review of study data, found that in rare cases, Dengvaxia can backfire: If people who never had dengue are vaccinated and later become infected, the vaccine may provoke a much more severe form of the illness,” the report says.
 
The World Health Organisation (WHO) is reviewing the situation and has issued an interim recommendation that only people who have had a prior dengue infection be vaccinated.
 
Sanofi too has said that the vaccine should only be given to people who have been previously sickened with dengue. Jack Cox, head of global media relations at Sanofi, told STAT , that “We propose that health care professionals would need to assess the likelihood of prior dengue infection in these individuals before vaccinating and for individuals who have not been previously infected by dengue virus, vaccination should not be recommended.”
 
However, the issue is most people do not know if they have been infected or no. Dengue could be a serious disease with severe complications. However, in many cases there are no or mild symptoms. In addition, there is no ‘readymade’ test available to determine is someone was infected in the past and now can be vaccinated.
 
The Philippines health secretary, Francisco T Duque III, had reportedly stated that the government is demanding a refund from Sanofi for the 3.5 billion Philippine pesos, or about $69 million, it spent on the vaccine. It is also asking the company to set up a fund to cover the treatment of any children who develop severe dengue.
 
According to a report from the New York Times, the Philippines government has begun investigations into the rollout of the immunisation program by Sanofi, which allegedly discounted early warnings that its vaccine could put some people at heightened risk of a severe form of the disease. 
 
Death rates are highest among children, and just last week a 7-year-old girl who had not been vaccinated died from dengue in the Philippines, says the NYT report, quoting agencies.
 
Dengvaxia, the world’s first dengue vaccine, had been developed by Sanofi over decades of research and is approved in 19 countries. 
 
Meanwhile, the Indian government is working on such vaccines and Phase 1 clinical trials of this vaccine is likely to be held in 2020. Minister of State for Health, Ashwini Kumar Choubey told the Rajya Sabha that DSV4, the vaccine developed by International Centre for Genetic Biotechnology (ICGEB)-Sun Pharma collaborative venture, is a recombinant vaccine on the Virus-Like Particles (VLP) platform with a tetravalent four-in-one VLP design; expressed in yeast, it elicits antibodies to all four DENV serotypes in a shorter schedule of 0, 1 and 2 months.
 
The other experiment involves the Panacea Dengue Vaccine, which is a cell culture-derived live attenuated, recombinant, freeze- dried, lyophilized tetravalent vaccine with the seed strain borrowed from the US-based National Institute of Health (NIH) and the Drug Controller General India had granted permission to conduct clinical Phase I/II studies, the Minister said.
 
Triggering public outrage, politicians in the Philippines are demanding information about Sanofi’s advertising campaign and their government’s aggressive push, against the advice of some experts, to vaccinate a million children. The backlash has alarmed researchers who worry that Sanofi’s stumble could stoke mistrust in vaccines around the globe. 
 
Dr William Schaffner, an infectious disease expert at Vanderbilt University, said, “It’s hard to think of another circumstance when a major public health program was introduced with this much controversy.”
 
The episode could prove to be a cautionary tale for pharmaceutical companies, who have already been reluctant to invest in vaccines and drugs that are used mainly in the developing world.
 
Sanofi saw the Philippines as a key market. In the fall of 2016, the company initiated a “disease awareness” campaign that did not name Dengvaxia but directed people to a Facebook page where Sanofi was mentioned.
 
The company has told investors that it expects to lose 100 million euros, or about $117 million, as a result of diminished sales. Sanofi is one of the world’s biggest pharmaceutical companies, reporting sales of nearly 34 billion euros in 2016, or nearly $40 billion. Two other dengue vaccines are in late-stage development and could threaten future sales of Dengvaxia if they show better results.
 
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    Ramesh Poapt

    2 years ago

    good article!

    Diet Helps Multiple Sclerosis Patients, Says Study
    Terry Wahls, a doctor, used to run marathons and climb mountains in Nepal. She earned a black belt in tae kwon do and competed multiple times in the American Birkebeiner 54-kilometer cross-country ski marathon. Then she developed multiple sclerosis (MS). By 2000, the disease had spread. Within two years, she could no longer play soccer with her kids. By fall 2003, walking from room to room for her hospital rounds exhausted her and, by summer 2004, her back and stomach muscles had weakened so much that she needed a tilt/recline wheelchair. The disability slowly progressed, despite increasingly aggressive therapy. By 2007, she spent most of her time lying in a zero-gravity chair. She was 52.
     
    Conventional medicine was failing her, a doctor. As she was heading toward a bedridden life, she began researching and experimenting on herself. She not only arrested her disease but achieved a dramatic restoration of her health—all through diet. Long after she managed to cure herself, a scientific study on the MS, published in  Neurology, the medical journal of the American Academy of Neurology, has found that better diet helps MS patients have less disability and fewer symptoms than people whose diet is less healthy. This is the conclusion of a study.
     
    The author of the study Kathryn C Fitzgerald, ScD, of Johns Hopkins School of Medicine in Baltimore, and a member of the American Academy of Neurology has been quoted as saying that “People with MS often ask if there is anything they can do to delay or avoid disability, and many people want to know if their diet can play a role, but there have been few studies investigating this... While this study does not determine whether a healthy lifestyle reduces MS symptoms or whether having severe symptoms makes it harder for people to engage in a healthy lifestyle, it provides evidence for the link between the two.” The study covered 6,989 people.
     
    Healthy diet was defined as eating more fruits, vegetables, legumes and whole grains and less sugar from desserts and sweetened beverages and less red meat and processed meat. The study divided participants were into five groups based on how healthy their diet was. Researchers also assessed whether participants had an overall healthy lifestyle which was defined as having a normal weight, regular physical activity and not smoking.
     
    People in the group with the healthiest diet were 20% less likely to have more severe physical disability than people in the group with the least healthy diet. The results were true even after researchers adjusted for other factors that could affect disability, such as age and how long they had MS. Individuals with the healthiest diets also were also around 20% less likely to have more severe depression.
     
    However, there are big differences between Dr Wahls’ diet and what was tracked by the study. Dr Wahls advocates a particular kind of diet (“Paleo Principles and Functional Medicine”) in her book The Wahls Protocol. The study claims to have studied the benefits of “diets that have been touted in self-help books and websites as beneficial for people with MS, such as the Wahls’ diet” but found that overall, “past or current use of these diets was associated with modestly reduced risk of increased disability.” Wahls Diet seems to have helped hundreds of MS patients. She suggests having three cups each of leafy greens vegetables, deeply coloured and sulphur-rich vegetables like broccoli, cabbage, radishes and so on, having wild-caught fish and grass-fed meat and avoiding gluten and dairy and. 
     
    This is the basic diet which gets progressively restricted over the weeks. Read the book in case you are dealing with an auto-immune disease. 
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    Ban on Junk Food Ads till 9pm: UK Experts
    A study by the Obesity Health Alliance, which includes several Royal Medical Colleges among its membership and the University of Liverpool, analysed TV commercials shown before and during some of the most popular TV programmes on the maximum number of children watch TV. They found that a single episode of a popular programme watched by an average of 140,000 children, showed as many as of nine commercials of high fat, sugar and salt (HFSS) products, in just 30 minutes from McDonalds, Domino’s pizza, Oreo and others. Paediatrics and child health experts have argued that junk food advertising should be banned within the family viewing hours of 6pm-9pm to combat the relentless rise in child obesity. 
     
    Dietary Guidelines: Against Conventional Solution
    Abunch of 26 doctors, many of them PhDs as well as MDs, led by Richard Feinman, had written a paper in 2015 in Nutritional Journal which is interesting in its approach and conclusion. It points out that the conventional recommendations of ways to improve health, and especially control diabetes, are simply not working. So, we need to open our minds to solutions that seem to be at the fringes, but actually deliver better results. The current dietary recommendations are to eat a low-fat diet to reduce obesity, cardiovascular risk, or improve general health. This does not seem to be improving health or reducing diabetes. For instance, rates of type-2 diabetes have quadrupled and obesity has nearly doubled in the US since 1980, the very year that the dietary guidelines were launched. Besides, there are persistent reports of some serious side-effects of commonly prescribed diabetic medications. On the other hand, low-carbohydrate diet in the treatment of diabetes and metabolic syndrome seems to be yielding better results without significant side-effects. 
     
    “All this points to the need for a reappraisal of dietary guidelines. The benefits of carbohydrate restriction in diabetes are immediate and well documented,” write the authors. “While concerns about the efficacy and safety are long term and conjectural rather than data driven. Dietary carbohydrate restriction reliably reduces high blood glucose, does not require weight loss (although is still best for weight loss), and leads to the reduction or elimination of medication. It has never shown side effects comparable with those seen in many drugs.” The authors presented 12 points of evidence supporting the use of low-carbohydrate diets as the first approach to treating type-2 diabetes and as the most effective adjunct to pharmacology in type-1. “They represent the best-documented, least controversial results… The 12 points are sufficiently compelling that we feel that the burden of proof rests with those who are opposed,” conclude the authors.
     
    Tactics of Infant Food Manufacturers Are Like Tobacco Companies 
    The nutrition chief of United Nations Children’s Fund (UNICEF) in Pakistan, Melanie Galvin has likened infant formula manufacturers to tobacco companies, charging that they have been using tactics similar to tobacco firms in the developing countries, after the West tightened the screws on them. Pakistan has banned infant formula marketing and samples in all hospitals. It has also put stricter rules on manufacturers that import such products. Ms Galvin said that Pakistan’s breastfeeding rates were going down because doctors were advising mothers to bottle-feed their babies. 
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