No Added Benefit from Most New Drugs, Finds Study
When it comes to healthcare, it turns out that new does not necessarily mean better. According to the findings of a research, published in scientific journal The BMJ, more than half of the new drugs entering the German healthcare system have not shown any new benefit. 
 
Dr Beate Wieseler and her colleagues at the German health technology assessment agency IQWiG (Institute for Quality and Efficiency in Health Care) say that international drug development processes and policies are responsible for this lapse and must be reformed. 
 
For the study, IQWiG assessed 216 medicines that were launched in Germany between 2011 and 2017. Most of these were approved by the European Medicines Agency (EMA) for use throughout Europe. Their analysis found that only a quarter of the new drugs brought any significant benefits over the existing treatments. The rest had only minor or no benefits, or the impact of the medicine was unknown. 
 
The study found that only 54 (25%) drugs were judged to have a considerable or major added benefit. While in 35 (16%), the added benefit was either minor or could not be quantified. For the other 125 (58%) drugs, the available evidence did not prove an added benefit over the standard care in the approved patient population. 
 
More particularly, the researchers realised that the situation is more shocking in some specialties. For instance, in psychiatry/neurology and diabetes, added benefit was seen in just 6% and 17%, respectively, of assessments. Even in the drugs that did show significant benefit, most of the research could only apply to sub-groups. “For the overall patient population, the current output of drug development may thus be resulting in even less progress than our assessments suggest,” the study reports. 
 
The study’s authors have said that some within the healthcare industry argue that limited information on a drug at the time of its approval is how things have always been done and it is simply the ‘price to be paid’ to provide patients with early access to new drugs. 
 
However, to refute this claim, the researchers revisited a study on cancer drugs that were evaluated by EMA and was conducted between 2009 and 2013. The study had found that most drugs had been approved with little evidence of any benefits to cancer patients’ quality of life or survival chances. After following up on the cancer drugs’ success rates, researchers found that little had changed on the effectiveness of the drug.  
 
The study also reports that drugs almost never undergo post-marketing studies after being initially approved and, even when a drug is found to be ineffective, regulators globally have failed to punish non-compliant manufacturers. “As a consequence, patients’ ability to make informed treatment decisions consonant with their preferences might be compromised, and any healthcare system hoping to call itself ‘patient centred’ is falling short of its ethical obligations,” says the study. 
 
The study reaffirms that healthcare professionals and patients have the right to impartial and complete information on what is to be expected from a certain treatment, including information on the benefit of alternative treatments or no treatment. But this, as the study reports is not possible with the current information gaps. 
 
Therefore, the authors have recommended a much stricter drug approval process that demands stronger evidence from long-term studies conducted on large, randomised control groups. Furthermore, ideally even after a drug is approved, research should continue to fill in any and all information gaps that may remain. 
 
The study also recommends changing the way these drugs are priced and incentivised—vague and unclear results are being rewarded with monetary gain, when actual tangible results should be the only final outcome that produces profit. 
 
In the longer term, health policy-makers need to take a more proactive approach, the authors suggest. “Rather than waiting for drug companies to decide what to develop, they could define the health system’s needs and implement to ensure the development of the treatments required.”
 
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    Ramesh Poapt

    1 month ago

    Good one!

    Intermittent Fasting Could Help Prevent Type-2 Diabetes
    Intermittent fasting, which means not eating during certain predetermined time slots in a day, has become more than just a dieting trend with numerous studies claiming it to be beneficial for prevention of obesity. Now, a new study has revealed that it could also act as a protective barrier against the development of type-2 diabetes. 
     
    These findings come from a study, conducted by researchers from the German Institute of Human Nutrition (DIfE), published in the journal Metabolism. The results indicate that intermittent fasting improves sensitivity to the blood glucose-lowering hormone insulin and protects against fatty liver. 
     
    Fatty liver has been thoroughly investigated as a known and frequently occurring disease; but little is known about the excess weight induced fat accumulation in the pancreas and its effects on the onset of type-2 diabetes. The team, led by Prof Annette Schürmann and Prof Tim J Schulz of DIfE, has found that overweight mice prone to diabetes have a high accumulation of fat cells in the pancreas. They realised that mice resistant to diabetes due to their genetic make-up, despite excess weight, had hardly any fat in the pancreas; instead, they had fat deposits in the liver. 
     
    “Fat accumulations outside the fat tissue, for example in the liver, muscles or even bones, have a negative effect on these organs and the entire body. What impact fat cells have within the pancreas has not been clear until now,” said Prof Schürmann, head of the department of experimental diabetology at DIfE and speaker of the German Center for Diabetes Research (DZD). 
     
    For the study, the research team divided the overweight animals, which were prone to diabetes, into two groups. One group was allowed to eat without any restrictions, i.e., as much as they wanted, whenever they wanted. The other group underwent an intermittent fasting regimen—one day, the rodents received unlimited chow; but the next day, they were not fed at all. After a period of five weeks, the researchers observed differences in the pancreas of the mice with fat cells being accumulated in the group who had no restrictions placed on food consumption. Conversely, animals in the other group had hardly any fat deposits in the pancreas.
     
    “Under certain genetic conditions, the accumulation of fat in the pancreas may play a decisive role in the development of type-2 diabetes,” said Prof Schulz, head of the department of adipocyte development and nutrition at the Research Centre.
     
    The collated data from this study does seem promising as it presents an alternate way to reduce liver fat and, consequently, prevent type-2 diabetes. Intermittent fasting could be a promising therapeutic approach in the future. The added advantage is that it is non-invasive, easy to integrate into everyday life and does not require drugs. But it is important to realise that this alone may not be enough to prevent the disease. 
     
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    RUSHIKESH YOGENDRA DHEBAR

    2 months ago

    Dear Akshay marvelous article which provides us day to day how to eat and ignore food in our life. Since long doctors advised to take intake in fracture timing 3/4 time in day. I have experience in two days straching eating and feel better one. Moreover you r requested to more research article on captions subject. God bless you

    Modern Foods Are Too Sweet, Reveals Study
    A comprehensive analysis of reviews by Amazon customers has revealed that modern food products are too sweet. This conclusion comes from a study that analysed food product reviews published on Amazon, over the course of a decade. 
     
    The study was conducted by researchers from the Monell Chemical Senses Center, who used a ‘sophisticated statistical modelling program’ to find words which relate to a variety of aspects pertaining to food products, such as taste, texture, odour, spiciness, cost, health and customer service. After collating, and sifting through the data, complaints about excessive sweetness within the reviews seemed to eclipse all others. Results of the study have been published in the scientific journal Physiology & Behaviour.
     
    “This is the first study of this scale to study food choice beyond the artificial constraints of the laboratory,” said lead author Dr Danielle Reed, a behavioural geneticist at Monell. Researchers looked at 383,568 food reviews published about 67,553 products, by 256,043 Amazon customers, over a 10-year period. With the assistance of machine learning algorithms, researchers were able to go through this vast archive and make determinations about the food, eventually realising that the majority of complaints were about how much sugar or other sweeteners were used in these items. “Sweet was the most frequently mentioned taste quality and the reviewers definitively told us that human food is over-sweetened,” said Dr Reed.
     
    “Reading and synthesizing almost 400,000 reviews would essentially be impossible for a human team, but recent developments in machine learning gave us the ability to understand both -- which words are present and also their underlying semantic meaning,” added study co-author Dr Joel Mainland, an olfactory neurobiologist at Monell.  
     
    The study found that the ‘too sweet’ complaint impacted nearly 1% of all food product reviews, with excessive sweetness being mentioned 25 times more than complaints about too little sweetness. Furthermore, 11% of the reviews described how sweet a particular product tasted, almost three times more than bitterness. Surprisingly, saltiness was rarely mentioned, even when there has been a lot of public health concern about excess salt consumption.
     
    To better understand individual differences in how people respond to a particular food, researchers looked at responses to 10 particular products that received the widest range of ratings - defined by the variability in the number of stars the product received. The analysis revealed that the two main factors that tended to account for polarising reviews for a product were: product reformulation and differing perspectives on the product’s taste. They found that people often rated the sweetness of a product differently. Response to a product’s smell also contributed to differences in opinion about a particular product. 
     
    “Genetic difference in taste or olfactory receptor sensitivity may help account for the extreme reactions that some products get and looking at the responses to polarizing foods could be a way to increase understanding of the biology of personal differences in food choice,” explained Dr Reed. 
     
    Overall, these results support the importance of taste in real world food ratings and individualised taste experiences, such as whether a product is ‘too sweet’. Researchers are confident that analysis of consumer review datasets is a promising methodology for the emerging field of sensory nutrition, as it can provide information about purchasing decisions and customer sensory responses to commercially available products.
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