Wednesday, September 21, 2016

Sponsored research, tailor made research and cooked up research-Credibility of food research at stake?

When it comes to research and development efforts, especially those with potential commercial application, who funds them becomes critical if the results of such scientific studies are to be credible. This is the reason why public funded research assumes critical importance for protecting the health of the citizen. In a country like the US, industry is in the forefront to offer financial assistance to Universities and other R & D institutions, the obvious purpose being touted as public interest. In contrast a country like India where resources are limited and industry is reluctant to open their purse for research in public organizations, most research is funded by the government. Is it not an irony that results generated by public funded agencies are not taken seriously by the industry due to many reasons while industry sponsored projects try to ensure that there is veil of secrecy attached to them for gaining advantage vis-a-vis the competitors. Thus renowned institutions in India like CFTRI, DFRL, NISTEM and a host of universities engaged in food R & D are repositories of knowledge generated over decades of research spending huge public money. Which system is preferable for the progress of a country is indeed a vexed question with uncertain answers.

The above issue came into sharp focus after a recent report about the unethical practices perpetrated by the sugar industry in the US to mislead the government as well as the consumers through "sponsored" research in some organizations using "friendly" scientists to deflect the truth that sugar is responsible for almost all the ills faced by the American citizens during the last 50 years. Words like Cardiac disease, diabetes, cancer, hypertension, kidney impairment etc are magnetic words that command immediate attention by people who are concerned about the terrible health disaster looming ahead of them and how each one of them can avoid succumbing to these ailments.  It is in such an environment that sugar industry sponsored and funded research sought to assure the citizens that there is nothing wrong with consuming sugar and the real culprits are saturated fats, cholesterol and lack of physical exercise. Even if they have a point in asserting about other factors, it is is nothing but fraud to suppress the results that showed adverse impact of sugar on health and continue to pump into the market products with high levels of sugar that stimulate the taste buds of most citizens. If sugar is so innocuous why is that the whole world is now trying to curb its consumption through persuasive as well as mandatory actions to force the food industry to reduce sugar levels in their products? Such research projects are more aptly called tailor-made research to suit the needs of the sponsorer rather than a genuine scientific research!  

One is reminded of the famous quotes of the CEO of the biggest soda company in the world where in consumers were advised not to bother about sugar in the soda but concentrate on physical exercise for maintaining their body weights. That shows the mindset of the food and beverage industry which has least priority as far as the health of the citizen is concerned or the quality of the environment he lives. Though the sugar industry tried to portray sugar as a safe ingredient through its tainted research efforts, it is now universally recognized that sugar is an addictive substance like opioids and habit forming and once hooked on it is next to impossible to keep away from sugar sweetened products. On the economic side down fall of sugar from its high pedestal can have severe financial impact on industries based on beverages, confectionery including chocolates, fruit preserves, canned fruit products and pastry products. Is it not a catch 24 situation? One cannot demolish the industry which provides gainful employment to millions of people while it is criminal to ignore the harmful effects, if any, of the products the industry churns out? That is probably the logic behind the approach of governments like that in the US not to be too harsh on the industry but use persuasive efforts rather than coercive methods to ensure healthy products are made in stead of suspect products too high in sugar, fat and refined carbohydrates. 

Sponsored research generally refers to programs funded by private players among the industry to achieve a certain result of their liking but what is nauseating is the tendency of the funding party to influence the results and bring out results that suit them. The sugar research mentioned above comes under this category. There are many other instances where such studies have been financially supported by the industry and obtained results that help to market their products among the unsuspecting consumers. An excellent example is the research sponsored by the cocoa industry to implant in the minds of the consumers that chocolates are healthy because it is supposed to contain antioxidants like flavanols. Sadly this is a red herring because the harsh processing conditions undergone by cocoa beans before they become suitable for making good quality chocolates do not help to retain much of the flavanols in the final product. On the contrary chocolates are rich in saturated fats and high in sugar making them a prime candidate as a causative substance for some of the life style diseases encountered to day. Even the new generation healthy chocolates now in the market containing upwards of 70% cocoa solids are suspect products with no proven health benefits. Imagine how this industry making obviously a unhealthy product is flourishing raking up billions of dollars of business all over the world! Probably most of the so called well being products in the market to day have not undergone any sound scientific studies with hardly any credible peer review. 

In a world starved of funds for research which after all cannot bring dividends in the short term, can the scientists refuse funding from the industry? Of course not. There must be some ethical standards which have to be followed while accepting such funding. Who will set such standards? This is the duty of the research organization in collaboration with the government. While product development may be a genuine area for industry funding, especially in a country like India where captive research set ups are far and few because the astronomical cost involved in establishing them, the R & D agencies must be careful regarding projects offered by the industry to support their unjustifiable health claims and far fetched agenda. India is fortunate in having organizations like CSIR, ICAR and ICMR with a vast network of R & D laboratories with a massive number of multidisciplinary scientists and all claims made by the industry must be verified before allowing to be marketed and if there is a resource crunch those who make the claim can be charged, at least nominally so that consumers can trust such claims when printed on the label.  

Coming to cooked up research, many of the studies undertaken by scientists and degree yearning research scholars are suspect as they do not face any real test regarding the veracity of their results. Those pursuing doctoral degrees are aware that no system exists to day that can challenge their results through repeating their studies to confirm the same! This is not to brush the entire research system with tar but to highlight the lacunae of the present university research system. There may be many honest scientists with unimpeachable integrity and honesty but they are far and few in to day's permissive atmosphere where every thing is accepted as truth without undergoing the veracity check. Internationally there have been many instances where research findings are retracted after a few years of their publication, more by accident than by any genuine checking system. If some of the R & D agencies working under government aegis have miserably failed the nation in delivering what is expected from them through development of global standard technologies, lack of reliability, trust of the potential users and failure to demonstrate under field conditions are responsible. One has to admire our scientists in space agency who cannot afford to fudge results because to ensure success of the space program their work has to be demonstrable and reliable for the entire country to see. It is this golden standard scientists in other fields also must set for themselves if they do not want to loose their esteem before the public.  


Sunday, September 18, 2016

Glycemic Index of foods- its relevance and reliability under a cloud

Diabetes is by now considered a debilitating disease which many viewing it as a silent killer. While educated people with some basic knowledge about the etiology of this affliction understand how the food we eat affects the blood glucose level and the adverse effect high glucose levels can have on different health parameters. It is sad to see millions of people suffering from diabetes, not very much aware of the consequences of eating high carbohydrate foods, that too based on highly refined ones, on the dynamics of glucose generation within the body and fall prey to serious ailments affecting eyes, heart, kidneys, limbs etc destroying the quality of their life. According to available reports there are more than 422 million people suffering from this disorder which is fast becoming a top killer among all the diseases. In India itself number of people afflicted by diabetes is placed around 62 million and if experts are to be believed, India may become the world capital of diabetes soon, if not checked effectively. Once diabetes is diagnosed appropriate diet and disciplined eating habits can provide substantial benefits along with correct drugs in right dosage. Inability of the body to assimilate sugar at a rate that will prevent undue build up in the blood, due to insulin insufficiency or insulin insensitivity has to be recognized and such build up can be "managed" only by a diet predominant in whole grains with particular emphasis on pulses, vegetables, meat, fish and nuts with low rate glucose release when consumed.

It is not that information is lacking regarding the type of foods that can be eaten moderately and the quantity that can be safe but often the logistical difficulties in adhering to a strict diet regimen besides often conflicting nature of such information, make it impractical to follow the guidelines of the physicians. Against such a situation the evolution of the concepts of Glycemic Index (GI) and glycemic load (GL) during early eighties provided a reasonably reliable guide to the ability of different foods consumed regularly to generate glucose in the body. Thus high GI, medium GI and low GI foods were developed or conceptualized that will safeguard against undue glucose spikes in the blood after consumption. But if recent reports by a group of scientists from the US are to be believed, GI is not as reliable as it was thought to be pushing millions of diabetics as well as the food industry developing products with low GI into a new era of uncertainty. What are the implications of the results of this study? 

Traditionally blood glucose levels, estimated after a 12 hour fasting  and 2 hours after ingesting a normal breakfast provided a reasonable clue as whether a person is diabetic or not. While a glucose level of 100 mg per 100 ml after fasting and 150 mg/100 ml 2 hours after breakfast are considered normal. Though there are slight variations in diabetic assessment technique essentially all of them highlight the ability of the body cells to assimilate free glucose from the blood for hundreds of biological functions. While high levels of blood glucose are supposed to cause hyperglycemic conditions considered dangerous, especially it it continues for long time, low levels of glucose cause hypoglycemic symptoms such as giddiness and over all weakness. Though these values are more or less accepted universally, monitoring blood glucose levels frequently, especially in the home environment is fraught with some logistical problems. Estimating glucose in a pathological laboratory may take at least a couple of hours but there are home gadgets based on mild pricking and drawing a tiny drop of blood on to a glucose oxidase enzyme strip that provides digital readings of glucose levels in a matter of a few seconds. Many people buy these gadgets for testing of glucose as and when they feel symptoms of hyper or hypo glycemia. A non-invasive system without the necessity of puncturing the skin is still in the realm of development and may take some time before becoming a common tool.

What is GI? Using a standard material like sugar for testing glucose transfer to blood from the food ingested is measured as a percentage of the time taken for the sugar to manifest in the blood, GI is expressed usually as a definitive number. Easily assimilable and fast appearance of glucose from the ingested sugar sources usually have high GI numbers while those foods which do not release glucose easily  have low GI values. Generally whole grains and pulses are slow glucose releasers and hence have low GI values. Most food products based on sugar and refined cereal flours have high GI values indicating that they cause glucose spikes in blood considered highly undesirable. Similarly processed foods containing high levels of retrograded starch and uncooked foods also have relatively lower GI values. Since a diabetic wants to avoid rapid rise in blood sugar levels, his choice is always foods with low GI numbers. Food industry also strives to evolve food products with less and less GI numbers to attract diabetes affected consumers and incidentally such tailor made foods also command higher prices.

It is almost a decade and a half since GI became a standard parameter for assessing suitability of different foods for consumption by diabetic affected people and no one has so far contested the relevance or reliability of GI to assess the glucose release and absorption by the blood. Of course from time to time there were informed criticism regarding the reliability of GI concept, in the absence of a better alternative, GI was still widely adopted by nutritionists and medical community as a practical tool. Though GI is widely used by physicians and dietitians for advising their clients regarding the best foods they must consume to control diabetes, periodic checking of fasting sugar and postprandial sugar levels still gives an idea about the extent of control of the food regimen by a diabetic patient.  Of course this traditional practice of glucose monitoring in the morning can at best give a picture about the glucose dynamics in the blood during pre-lunch period.  What about the situation in the post lunch period? Though many diabetics use home gadgets to monitor the blood glucose level as many times as they wish, it is not practical to do this often due to the physical discomfort involved in skin puncturing. The concept of glycosylated haemoglobin (HbA1c) measurement in the blood once in 2-3 months provides a reliable means of knowing about the history of food eating during that period. While a value of less than 6 is considered normal, any value beyond that can be an indicator of onset of diabetes. Values beyond 7 must be taken seriously to exercise better control of the diet by including more and more of low GI foods in their diet. 
One can realize how far the world has gone in adopting GI as a useful tool to manage diets. It is this edifice which is sought to be destroyed by the findings of a group of scientists in the US who claim that GI is not as dependable as it is thought to be, because of inconsistent values of GI noted for the same food in different people. While minor variations up to 5% can be ignored because of experimental error that may creep in in different laboratories, variations as big as 20% cannot be attributed to lab error. If their results are true the commonly consumed white bread can show GI values ranging from 47 to 77! This means white bread can be a low GI food for some, medium GI food for some body else and a high GI food for some others. How ludicrous it is? But if the results of the American scientists are validated, it is going to open a Pandora's Box with unimaginable consequences. Low GI foods have values 35-55, medium ones 57-67 and high GI category with GI 70-103. More shocking is that same food with a certain standard GI value gave widely different values in the same person when determined on different occasions according to these scientists! What can one make out of these observations and what impact it will have on various stakeholders of the diabetic disease?.

It is unfortunate that the new studies have come at a time when some consensus is emerging about the need for the food industry to include in the label information regarding the GI value of the contents within the packet. Will this be the pretext for the manufacturers to resist pressure from the consumer community to publish GI data on the label? That should not be allowed to happen at any cost unless more studies are organized to validate the new findings. Even if GI values show variations under different conditions, by and large they seem to remain same most of the time. Similarly it does not matter that GI response varies from person to person since most data applied to day is based on majority response. Till a new and better alternative energies, it may be fool hardy to ignore it for the time being. Diabetics are better advised to base their diet on low GI foods and best way to manage diabetes could be to adopt diets based on foods undergoing minimum processing.

The million dollar question is whether hundreds of scientist working on GI of foods have gone wrong some where? What can be the scientific explanation for this shocking anomaly? A larger question is if there are such wide metabolic and physiological variations amongst human beings, what relevance studies using humans as subjects can have in generalizing the results of such studies to be applicable to entire humanity? This question assumes more significance when human studies are undertaken while testing drugs for various ailments and diseases. It is urgent that the questions raised by the Tuft university scientists are further examined by a few independent groups under international collaboration to arrive at a consensus. If Gi tool is to be thrown out of the window what other alternatives we have to assess appropriateness and soundness of foods for consumption by diabetic population? No body disagrees with the universal consensus that fruits, vegetables, whole cereals, pulses and foods rich in retrograded starch must constitute the core part of any diet but to make them palatable appropriate products have to be evolved acceptable to the targeted consumers.  .     


Thursday, September 1, 2016

The "Bromate in bread" controversy-Where lies the truth?

The recent controversy regarding the presence of potassium bromate residues in bread and other wheat based bakery preparations does not help either the consumer or the industry. While it showed bakery industry as a villain, consumers became weary about the industry giving an impression that the products churned out by this sector are not safe. According to the organization which splashed this news based on a study of a few samples picked up from the Delhi market, since bromates are carcinogenic, bread made with this chemical is not safe for human consumption. Probably it may have a point and safety authorities need to look into this issue more carefully and dispassionately. Decision to ban must be taken based on facts and ground reality, not as a knee-jerk reaction. What is not understandable is the haste with which the authors of this study had gone to the press which can only serve to create panic among the consuming public. FSSAI, the "Authority" sitting in Delhi seems to have been woken up from its slumber mode and since it has authority to ban any products as it did with maggi noodles last year, one can only expect a similar reaction from this babu organization. But it is time the consumers realize the reality, give the report a cursory glance and go on with their lives till more definitive data emerge on this issue.

According to the Center for Science and Environment, a Delhi based consumer watch dog, Indian bread may cause cancer because of the existing practice of the baking industry using potassium bromate for improving the raising quality of the bread. Not only that it also includes besides bread other products like pizza, burger etc as potential cancer causing products about which consumers must be aware. It further declares that potassium iodate, an approved additive in bakery products, has the potential to adversely affect thyroid functions in human beings and therefore needs to be banned. Lo, there goes the declaration by the FSSAI banning bromate for use in food products in India and further assures the public that it would examine iodate regarding its ill effects on humans! Steps in our over concerned Mantriji, the custodian of health of the population in India, cautioning the public against panic as he is "fully seized" of the matter. He further assures the public that a thorough investigation will be undertaken to find out whether these chemicals already approved by FSSAI are really dangerous and take "appropriate action" if so. Of course every body knows that he and his ministry will promptly forget about this issue and move on to the mundane things they are doing to protect the health of Indian people!  

For those not knowing what is potassium bromate and why it is used in bakery products, it is appropriate to peep into into its history. Potassium bromate, or commonly referred to as bromate, is an oxidiser deployed to strengthen wheat dough so that its elasticity is increased, besides helping to get a uniform bake and white color for the final product viz bread. Usual practice is to use 15-30 parts per million (ppm) of potassium bromate in the flour before making the dough. For a number of years this chemical was being used extensively by the baking industry across the world with no adverse report coming from any where. One of the reasons why it is considered a safe practice is that bromate gets destroyed at the high baking temperatures which is required to make a good bread. It is well known that at the baking temperatures normally no residue is supposed to be left behind to cause any ill effect. Of course if good manufacturing practices are not followed, especially use of high concentrations of bromate or under baking, possibility of some residue remaining cannot be ruled out. 

Is use of bromate confined only to India? Of course not. There are a few countries like the US which permit use of bromates but under the condition that there is zero residue left in the product after baking. Many countries, to be on the safer side out rightly banned use of bromates. Though earlier a limit of 75 ppm was allowed which was reduced to 60 ppm later, subsequent international studies did find bromate to be of carcinogenic potential and advised all countries to avoid using it as far as possible since alternative safer additives are available to achieve the same objective as a flour improver. It was in 2012 that the Codex Alimentarius Commission of FAO/WHO withdrew specifications for bromate from its official list implying that its use should be discontinued. However, India, though a member of the Codex did not bother to implement the recommendations of this body and continued permitting bromate in the country for reasons known best to FSSAI. Is it not ironical that FSSAI has to be woken up by the limited studies of the Delhi organization to remove bromate from the list of permitted food additives? 

Before we take the side of the consumer, it is only fair to listen to the compulsions of the bakery industry in India as to why it is persisting with the use of bromate, in spite of the adverse views of the Codex. Most logical explanation would be that it is legally permitted in the country and no one can find fault with it. Interestingly in a country like the US where 60-75 ppm of bromate is legally allowed many major bakery players have shunned its use voluntarily, finding alternate flour improvers like  ascorbic acid, ammonium persulfate, ammonium chloride, amylase, glucose oxidase  etc. The attraction for the industry to use bromate is that it is the cheapest flour improver in the market, all others costing considerably more. It is the contention of the bakery industry that if it is forced to stop use of bromate, the bread prices may go up due to increased cost of manufacture. Probably this is an argument no body is going to buy that easily! The industry feels that since FSSAI does not want to shoulder the responsibility of monitoring the bromate residues in bread regularly, it is exercising its power to ban this chemical. May be there is a point but responsible industry leaders must understand that monitoring thousands of small and micro scale bakeries across this vast country is not that easy and therefore it must accept gracefully the decision to discontinue use of bromate in the country. As for potassium iodate it is not used widely in India in food preparations though it is a recommended source of iodine for fortification of salt to prevent on set of the goiter disease among the population. Probably banning this chemical may affect the salt fortification project promoted by the government. 

If the industry is to be believed the report by the Delhi organization regarding the safety of bread in India based on a limited study confined only to Delhi has caused a severe backlash against bakery products in the country as it has touched a raw nerve among the consumers, causing significant damage to its business. May be it has a point as voluntary organizations publishing such reports needs to be controlled and there should be an alliance between such groups and the government for exchanging such information before making them public. After all GOI has big institutions like CFTRI, CDRI, NIFTEM, etc and veracity of such panic causing reports must be vetted by peer scientists from these institutes before being put on the public domain. However well equipped voluntary organizations are, their facilities and experience cannot come any where to that of GOI food research institutions and hence this caution.