Another Dangerous Rotavirus Vaccine

Clinical trial of the new rotavirus vaccine from the Serum Institute of India shows that the vaccine increases the incidence of diarrhoea instead of decreasing it.

 
The vaccine was field tested in Niger in Western Africa. The results were published in the prestigious New England Journal of Medicine (NEJM). The authors report that vaccine efficacy was 66.7% against severe rotavirus diarrhoea. What was not highlighted was that diarrhoea caused by other agents increased significantly and the vaccinated children had more diarrhoea than those not vaccinated.
 
The NEJM has this week published a letter in response to the original article, which shows that there was a significantly higher rate of gastroenteritis and diarrhoea in the vaccinated group compared to those given the placebo - an inert dummy vaccine. The NEJM letter points out that this vaccine could aggravate the problem it is meant to solve in resource-poor countries. An anti-diarrhoea vaccine that increases the incidence of diarrhoea is unlikely to find a market. 
 
This is not the first rotavirus vaccine that is under a cloud for not being upfront with trial data. 
  
Adverse Effects with Rotavac (Bharat Biotech India)
Another vaccine, Rotavac, manufactured by Bharat Biotech was recently in the news for not disclosing adverse events in a vaccine trial. This vaccine was tested in three centres in India. It appears there was a significant increase in the incidence of intussusceptions - a potentially life threatening complication where the intestine telescopes into itself and can become gangrenous - at the Vellore centre. This data from Vellore has not been published in spite of repeated requests for it from various quarters, including from the Prime Minister's Office (PMO).
  
In response to a public interest litigation (PIL) filed in the Delhi High Court, lawyers for the opposite side argued that "…site specific data on safety is inappropriate for release as per protocol and its inappropriate interpretation or publication, which would lead to disinformation about the product (that has been) developed by government with great effort and expense, and will give unfair advantage to multinational products which were never tested in India, (and) yet (were) licensed."
 
Rotavac has now been licensed in India and the vaccine is being administered in a Phase IV trial without informing parents of the risks observed in the randomized control trial in Vellore - a clear violation of basic ethical values.
 
This phenomenon of incomplete and inaccurate reporting of crucial clinical trial data is not limited to Indian manufacturers of vaccines. GSK recently tested its vaccine in Bangladesh and the outcome was similar. 
 
Rotarix (GSK) in Bangladesh
PLoS Medicine , a peer-reviewed weekly medical journal, recently published the results of the Rotarix trial in Bangladesh.  The PLoS Comments by Deepak Jain and Deepak Mittal point out that the purpose of the vaccine is to reduce the overall burden of disease from diarrhoea and diarrhoea deaths. However, there were more cases of children reporting diarrhoea among those vaccinated with Rotarix in Bangladesh, although this increase in diarrhoea was not statistically significant. The fact remains that this vaccine did not reduce diarrhoea among the vaccinated - in spite of its exorbitant cost.  The authors have not responded to the comments till now.
 
It all boils down to making a profit. Misrepresenting research findings, cherry picking data, and concealment of adverse events in clinical trials are now seemingly acceptable practices.
 
(Jacob Puliyel is a member of the National Technical Advisory Group on Immunisation, Government of India. The views expressed are his own.)
 
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Pulse Beat
Low-fat Diet Leads to Obesity!
Dr Aseem Malhotra is a star cardiologist of the UK who has been getting a lot of attention these days. In late April, he wrote an article in Men’s Health magazine titled, “The Truth About Fat and Sugar is Finally Explained”, that has been reproduced in The Daily Mail and is being widely discussed. He writes: “This morning, as I do most days, I breakfasted on a three-egg omelette cooked in coconut oil, with a whole milk coffee. I enjoyed a wedge of full fat cheese with my lunch, poured a liberal dose of olive oil on my evening salad and snacked on nuts throughout the day. In short, I ingested a fair amount of fat and, as a cardiologist who has treated thousands of people with heart disease, this may seem a particularly peculiar way to behave. Fat, after all, furs up our arteries and piles on the pounds—or at least that’s what prevailing medical and dietary advice has had us believe. As a result, most of us have spent years eschewing full fat foods for their ‘low fat’ equivalents, in the hope it will leave us fitter and healthier. Yet I’m now convinced we have instead been doing untold damage: far from being the best thing for health or weight loss, a low fat diet is the opposite. In fact, I would go so far as to say the change in dietary advice in 1977 to restrict the amount of fat we were eating helped to fuel the obesity epidemic unfolding today.” 
 
Dr Malhotra goes on to write about a series of recent research papers and ideas from global experts that pin the blame on refined carbohydrates and sugar that are responsible for heart disease, diabetes, obesity, cancer, and many maladies. In Sweden, up to 23% of the population is embracing a high-fat, low-carbohydrate diet. The obesity rates are falling in Sweden. As Dr Andreas Eenfeldt, who runs Sweden’s most popular health blog, Diet Doctor, says: “You don’t get fat from eating fatty foods just as you don’t turn green from eating green vegetables.”
 
Dr Malhotra points to a 2013 research, wherein a group of academics studied previously unpublished data from a seminal study done in the early 1970s, known as the Sydney Diet Heart study. They found that cardiac patients who replaced butter with margarine had an increased mortality rate, despite a 13% reduction in total cholesterol. Also, the Honolulu heart study, published in the Lancet in 2001, concluded that for those above 60 high total cholesterol is inversely associated with risk of death! Dr Malhotra points out that “when it comes to diet, it’s the polyphenols and omega-3 fatty acids abundant in extra virgin olive oil, nuts, fatty fish and vegetables that help to rapidly reduce thrombosis and inflammation, independent of changes in cholesterol. Yet full fat dairy has remained demonized—until now.” If you want to read the whole of this fascinating article go to http://www.menshealth.co.uk/food-nutrition/the-truth-about-fat-and-sugar-is-finally-explained
 
What They Don’t Teach in Medical Schools 
Dr Rangan Chatterjee demonstrated on the BBC show, Doctor in the House, in October 2016 that type-II diabetes could be diagnosed and reversed within 30 days with simple lifestyle changes. But Dr Chatterjee didn’t learn this in a medical school which all over the world, more so in India, don’t impart basic knowledge about nutrition and the impact of exercise on tackling ailments. A study carried out by Professor Chris Oliver’s team at Edinburgh University revealed that only 14% of medical students knew the chief medical officer’s physical activity guidelines!
 
Making nutrition and health (lifestyle treatment) an important part of medical curriculum in medical schools can save a lot of money for the overburdened public health system and free up resources, squandered on medicines and procedures, for better uses. Diet and lifestyle, as medicine, used to be part of all old medical knowledge base but we seem to have sacrificed it at the altar of medicines and machines.
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COMMENTS

Ankur Bamne

2 years ago

were the proofs of this article run through Dr. B.M. Hegde? The article mentions 'star' cardiologist! He must be very very upset! He cannot start an article without taking a jab at cardiologists :-!

India has to save yoga from its shallow, soulless imitations
With weird concoction like "Beer Yoga" getting popular as the next big international fitness craze, the ancient art of inner blossoming is seemingly going topsy-turvy. And as yoga hogs the limelight on its third International Day, the loud call for saving the spirit of the ancient and modern practice can't be swept under the carpet.
 
While yoga needs to be promoted as a life-transforming phenomenon, it wouldn't do much good if it loses the balance of purity and ingenuity.
 
From being an ancient spiritual pursuit for those seeking enlightenment and becoming a hippies' fad, yoga has shown remarkable flexibility to become the most-chanted lifestyle mantra of today. From laptop models to fitness clubs, none wants to miss the bandwagon. But as it mainstreams itself, there is also the danger of getting it diluted into a shallow but widespread phenomenon.
 
With other strange rejigs like "Naked Yoga" claiming to share its revered lineage, the argument that yoga is losing touch with its roots, its history, even its soul is bound to gain some traction. That makes India's state-backed bid to reclaim it good for yoga.
 
India can only rue her past apathy for allowing yoga to be stripped and raped. In the guise of secularism, India shied away from protecting and promoting yoga for too long. The powers that be never made any attempt to ensure standardisation or harness it as a national asset. The vacuum allowed a free run for shallow imitations.
 
There was no vision to hard-sell yoga as a trusted Indian brand, despite surging demands across the world. It was only in 2015 that the Ministry of AYUSH launched a scheme for voluntary certification of yoga professionals in alliance with Quality Council of India (QCI). Thanks to it, India at last has over 1,000 certified yoga professionals. It is shameful statistics as the US' largest yoga teacher registry alone adds around 15,000 new trainers each year.
 
Apart from ensuring quality, such certification will check dilution as more and more trained hands will be available to steer the global yoga boom. On that front QCI, operating through its Yoga Certification Steering Committee, has done a good job by setting comprehensive and inclusive standards for training and certification.
 
"The strict QCI certification norms and the training needed to clear them ensure that a certified instructor is thorough with the basic philosophy of yoga. As the premium on certification rises, people will realise that becoming a yoga instructor takes a lot more than just demonstrating or practising yoga postures," says Shabina Ansari, a Pune-based QCI Level II yoga teacher who recently cleared the certification after going through 350 hours of intense yoga training at Bengaluru-based Sri Sri School of Yoga of the Art of Living.
 
That bar on quality is critical as India has a moral duty to defend yoga's spiritual traditions. The challenge is to get people thinking about its roots while not scuttling its rapid globalisation. The pitch for quality must not end indirectly telling people to stop practicing yoga.
 
The great debate over whether yoga has sold its soul is no more limited to the perils of the West's obsession with its physical aspect (asanas) and growing commercialisation. The focus must now shift to checking the trend of passing anything and everything as yoga.
 
Even though yoga is often taught like a series of physical exertions done to get fit, everyone sells it on its loftier charm of taking inner calm to the next level. Even the original "Beer Yoga" ad touts itself as the "marriage of two great centuries-old therapies for mind, body and soul" and claims it pairs the philosophies of yoga with the pleasure of beer drinking to take on to the highest level of consciousness.
 
Yet, the spiritual aspect is often given the miss. Practically, yoga is widely sold without its soul. Some even among the puritans believe that to welcome the greatest number of people, yoga has to dilute itself. They think its original incarnation carries too much baggage. But the reality is that yoga can be taken to every corner of the world without diluting its essence.
 
Body postures are just one of the aspects required for yoga practice. The others include adherence to social and personal ethics, control of breathing and senses and devotion and meditation. This is where quality check and certification will do wonders.
 
The International Day of Yoga is the perfect stage for India to show the world that yoga can go places without losing it soul. In that, quality will matter a lot.
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.
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