Changes in the ancient microbiome may be leading to more modern disease

My story in Open

http://www.openthemagazine.com/article/living/our-basic-bug-instinct

Indian ecologists turn to crowdsourcing

My article in Nature India. Free registration needed to view article.
http://www.nature.com/nindia/2013/131120/full/nindia.2013.152.html

Cancer is as natural as ageing

My review of the fascinating book The Cancer Chronicles and an interview with its author, George Johnson.
http://www.openthemagazine.com/article/living/cancer-is-as-natural-as-ageing

Can cellular ageing be reversed?

My story on research into telomere-lengthening interventions for reversing ageing.

http://www.openthemagazine.com/article/living/the-battle-against-ageing

Collateral damage

Public-sector and NGO research into GM foods could be an alternative to Monsanto. 
http://www.openthemagazine.com/article/business/collateral-damage

Can the collapse of an ecosystem be foreseen?

A while back, I met theoretical ecologist Vishwesha Guttal of the Indian Institute of Science’s Centre for Ecological Sciences and discussed his work on early-warning signals for ecological changes. Guttal’s research is fascinating, and forms part of a growing body of work on tipping points. The upcoming issue of Theoretical Ecology, where Guttal’s latest paper appears, is devoted to this area of research.

Guttal’s work revolves around the concept of ‘catastrophic regime changes’ (CRC) in ecological systems. While the term may sound like the subject of a Hollywood disaster film about tsunamis and earthquakes, a catastrophic regime change need not be as dramatic.  It is simply a sudden change in an ecosystem from one state to another in a relatively short time (as opposed to a slow and gradual change). When a semi-arid region turns into a desert over a short period of time, an ecologist would call it a CRC.

Another example of a CRC is eutrophication---the reason why several of Bangalore’s lakes, such as Varthur and Bellandur are dying out.  When too many nutrients like nitrogen and phosphorous are pumped into lakes (through sewage, detergent, effluents etc.), algae multiplies,  the lake loses its transparency and aquatic plants under the surface are not clearly visible anymore. As oxygen levels drop because of excess algal growth, some important species of fish die away, while others begin to dominate.  

Ecologists say eutrophication can often be a *sudden* phenomenon---that is, even though the  nutrients are being pumped into the lake steadily over many years, the lake resists change and remains in its clear state. This goes on until a tipping point occurs. At this point, a mere incremental increase in nutrient input leads to a dramatic change in the lake, which clouds over in mere months.

The concept of CRC doesn’t apply to lakes and deserts alone.  Some researchers have speculated that the Indus Valley civilization could have come to an end due to changes in monsoon patterns, causing its rivers to dry up suddenly. A 2009 review paper in Nature by Martin Scheffer et al. draws dramatic parallels between epileptic fits, asthma attacks, stock market crashes and ecosystem collapses, describing these as systemic failures that are triggered by similar mechanisms.

But can scientists predict such failures? 

While research in this area is still nascent, scientists such as Guttal have suggested several statistical predictors for CRCs. In a 2008 paper published by Guttal and C Jayaprakash in Ecology Letters, they suggested that “changes in the asymmetry, quantified by changes in the skewness of time series data, can be a generic indicator of an impending regime shift.”

                                                                  

In the context of lake eutrophication, the time series data would be phosphorous levels at various points in the lake, collected over a period of time. As these levels fluctuate more and more against their mean (increased skewness), one can expect eutrophication to occur.

                                                                  

In the past, researchers would typically measure mean phosphorous levels in a lake and plot it over time. As the mean increased with time, they would take it as an indicator of an impending CRC.  This is a simple enough conclusion, since higher phosphorous levels lead to eutrophication.

What Guttal and Jayaprakash’s paper says, however, is that the mean phosphorous level alone cannot tell much. Instead of the average, it makes more sense to track phosphorous levels at various points in the lake and calculate how much they vary against the mean. Measuring the asymmetry of these fluctuations (skewness)  would indicate an upcoming tipping point.

Can these methods be used to predict monsoon failiures?

The statistical methods described above may someday be useful in predicting even monsoons. This is a long shot, but researchers are already working along these lines. Guttal points to a 2005 paper in Geophysical Research Letters by K Zickfield et al., which suggests that the Indian monsoon may have two stable states (a wet monsoon and a low precipitation monsoon). Further, changes in sulphur emmissions, land use, insolation and CO2 concentrations, driven by human activity, could trigger a transition from one stable state to another. If this is true, then the statistical observations by Guttal and other scientists working on tipping points could help predict monsoon failures by studying factors such as rainfall patterns.

Extending this further, the desertification of semi-arid areas could be predicted by examining vegetation patterns. Vegetation can grow in various patterns, such as spots and stripes. Guttal is working with the Department of Aerospace engineering on the new IISc campus near Chitradurga district of Karnataka, as well as in the deserts of Rajasthan, to deploy unmanned aerial vehicles to capture these patterns and tease out a connection between them and ecosystem changes.

As I said earlier in this post, this field of research is still nascent. To successfully apply these statistical predictors to real life would require a tremendous amount of data and several other variables. Guttal adds that in addition to data, a systematic methodology and toolkits are needed to help foresters and ecosystem managers  apply these methods. A 2012 paper by Dakos et al (including Guttal) in PLOS One makes an effort in this direction. This paper comes with a software package in programming language R, that accepts inputs of time series and quantifies early warnings.  

Meanwhile, policy makers are also looking at such statistical methods for predicting catastrophic risks, as this paper from the International Risk Governance Council shows.

The Endosulfan ban and the scientific debate that didn't happen

This post also appeared on Spicy IP

Kerala’s Endosulfan Ban---The science that never got discussed

While researching my article in Open Magazine on ‘Kerala’s endosulfan tragedy---Did it really happen?’, I came across several controversial points of view among the scientists I interviewed. These views have never really been debated in India, and probably never will, given the politicization of the events in Kerala. But in an ideal situation, they should have.

Increasingly (not just in India, but the world over), there is a tendency to conflate several issues surrounding a subject. In the case of GM foods, environmentalists conflate health effects, farmer suicides, super-weeds, contamination by transgenes, and Monsanto’s monopolistic practices, in their argument against GM foods. But these are five distinct issues, with five different sets of arguments. Here is an excellent article in Nature that separately addresses three controversial GM-related subjects and summarizes the state of evidence in each of them.

Similarly, in the case of the endosulfan ban, there were two separate questions---a) Were the diseases in Kerala caused by endosulfan? b) If they weren’t, should India have banned endosulfan, invoking the precautionary principle?

My story, which can be accessed here, argued that there was no credible epidemiological evidence that the diseases in Kasargod were caused by the aerial spraying of endosulfan.

But I did not address the other part of the debate. Should India have banned endosulfan?  

My research made me realize how divided scientists are on this issue. Interestingly, the differences are mostly about the policy decision to ban endosulfan, and not about the scientific ‘facts’ this decision was based on. There was broad consensus on the properties of endosulfan. And one thing I can say for sure is that contrary to what environmentalists claim with so much confidence, it is not a ‘well-known fact’ that endosulfan is bio-accumulative and harmful to humans.  

To understand the ‘facts’ of the issue, one needs to understand the criteria the Stockholm Convention uses to label a chemical as a persistent organic pollutant or POP. A POP is defined as a chemical that has four properties. First, it is persistent in the environment and does not degrade for long periods of time. The Stockholm Convention says chemicals with a half-life of more than 6 months in soil are POPs.  Second, the chemical should be capable of accumulating in living creatures---i.e, the rate at which an organism absorbs it should be greater than the rate at which it excretes it. Third, the chemical should be capable of long-range transport. And last, the chemical should impact human health adversely.

Let’s begin with persistence.

According to Ivan Kennedy, a professor of environmental chemistry from the University of Sydney with  numerous published papers on the behavior of endosulfan,  the data cited by the Stockholm Convention’s POP review committee to prove that endosulfan has a half-life greater than 6 months was either laboratory data or data from arctic regions. Both tend to be extreme values. Average values should have been used, considering that in warm, tropical climates, where 95% of the world’s endosulfan usage occurred till recently, endosulfan’s half-life in soil is much lower than six months.

In a document titled “Invalid basis for listing endosulfan as a POP: A critique with strong evidence that the Stockholm Convention is exceeding its mandate, ” Kennedy systematically questions the relevance of each bit of data cited by the Stockholm Convention’s POP Review Committee as evidence that endosulfan is a POP. He says these data and papers were cherry picked and did not reflect field conditions in tropical climates. Further, the process of listing endosulfan as a POP did not include peer-review, and therefore, could easily have been hijacked by political motivations.

I reached out to three of the scientists whose papers Kennedy said were cherry picked. In essence, Kennedy said that while the studies by these scientists were of good quality, they do not show that endosufan is persistent in the field, because they are lab studies. The scientists I contacted were N Sethunathan (author of ‘Persistence of Endosulfan and Endosulfan Sulfate in Soil as Affected by Moisture Regime and Organic Matter Addition’, Bulletin Environmental Contamination and Toxicology, 2002 ), Volker Laabs (author of ‘Fate of Pesticides in Tropical Soils of Brazil under Field Conditions’, J. Environ. Qual, 2002), and N Vasudevan (author of ‘Effect of Tween 80 added to soil on the degradation of endosulfan by Pseudomonas aeruginosa’, International Journal of Environmental Science and Technology, 2007).

Their responses were fascinating.

N Sethunathan believes endosulfan is persistent. But he agrees that his study was a lab study, as Kennedy alleges, and not a field study.

N Vasudevan said his study did not measure ‘persistence’ and half-life at all. They were only measuring prevalence of the pesticide and distribution in soil.

Volker Laabs agreed that his study was a lab study, but believes it is still relevant to the Convention’s decision. But he also agreed that endosulfan is unlikely to be persistent in tropical climates such as India.

All in all, I’d say Kennedy’s arguments bear out.

Next, I spoke to another UK-based environmental chemist, Crispin Halsall, of the Lancaster Environment Centre. His 2010 paper “Endosulfan, a global pesticide: A review of its fate in the environment and occurrence in the Arctic” in the journal Science of the Total Environment is also cited by the POP Review Committee. Further, Halsall advised the Committee and believes the decision to classify endosulfan as a POP was correct.

When I ran Kennedy’s arguments past him, however, Halsall seemed to agree with them broadly. He agreed that endosulfan is not persistent or bioaccumulative in tropical climates, but argued that even POPs like DDT behaved differently in different climates. However, he agreed that evidence of harm to human beings was not conclusive.

But his main point really was that even if there is inconclusive evidence about the health effects of endosulfan, it is enough to invoke the precautionary principle. According to him, classifying chemicals such as DDT as POPs was easy, because they were such obvious POPs. But with chemicals such as endosulfan, the evidence is weaker. Increasingly in the future, he feels, there will be more debate as chemicals such as endosulfan, which are ‘on the cusp’, come up for inclusion among POPs.

The first twelve chemicals to be classified as POPs by the convention were known as the Dirty Dozen. These included DDT, chlordane and dieldrin. These are “true POPs”---chemicals whose properties make them very obviously toxic. These chemicals easily meet the Stockholm Convention’s criteria. This means their half lives in soil are clearly higher than six months; they are clearly bioaccumulative; they travel long ranges; and they clearly effect human health.

But endosulfan is on the cusp. It may have some properties similar to true POPs, but in other ways, it behaves very differently.

Given all this, Keith Solomon, a professor of environmental science at Canada’s University of Guelph, feels the precautionary principle is just being used as a political tool in the endosulfan case. In a paper published this year in the Journal of Agricultural and Food Chemistry, Solomon authored a section on endosulfan, broadly making the same points Kennedy did in his criticism of the Convention’s decision. Solomon believes the use of precautions is enough, given the evidence on endosulfan, and that classification as a POP was an overkill.

What makes this debate more interesting is that Solomon is a co-author of the Science of the Total Environment paper, together with Crispin Halsall. Basically, two co-authors of the same paper disagree on the subject they are summarizing.

Given this background, let’s cut back to India.  First, why does India need endosulfan?

I quote from my story in Mint in 2011. “India is the supplier of 70% of the world’s endosulfan needs—a market valued at $300 million (Rs 1,340 crore). Out of the 9,000 tonnes India produces every year, half is bought by the country’s 75 million farmers, making it the world’s largest consumer of endosulfan. Much of it is used by farmers with small and marginal holdings, because endosulfan is cheap—Rs 286 per kg—and has a broad spectrum of effects. Alternatives such as flubendiamine and imidacloprid cost Rs 13,800 and Rs 2,229 per kg, respectively. Endosulfan is sprayed on all major crops such as vegetables, cotton, pulses and rice to combat pests such as whitefly, leafhoppers, aphids and cabbage worms, without harming insects such as bees, which help in pollination. “This is one of the safest insecticides for pollinators,” said A.K. Chakravarthy, entomology department head at Bangalore’s University of Agricultural Sciences (UAS).”

So, clearly, banning endosulfan would have a very significant impact on farmers’ livelihoods.

Let me add that being friendly to pollinators such as bees is no small deal.  Among the alternatives to endosulfan that were proposed by the Stockholm Convention, Imidacloripid is already being implicated in bee colony collapse disorder. Also, endosulfan has been used for so many years that there is enough data on how to use it safely. The same cannot be said about newer pesticides such as Flubendiamide. All pesticides, by nature, are toxic. Should we, then, prefer a pesticide that we have more data about, or switch to a newer, less-tested one, driven by fear?

Another alternative to endosulfan that the Stockholm Convention suggested was organic farming. I tried very hard to determine the impacts of organic farming in Kasargod after the ban on pesticides. C Jayakumar, an environmentalist with Thanal, an NGO which was a major campaigner against endosulfan, told me in an email that organic farming was working out fantastic for Kasargod.

But, as always, there was another side to the story.  

K M Sreekumar, the entomologist I quoted in my article, gave me the example of a rice farmer whose 400 acre crop was destroyed by an attack of leafhoppers, because endosulfan had been banned, and no suitable organic alternative was available yet.

Unfortunately, the Plantation Corporation of Kerala does not release data on cashew yields. So there is no way of knowing if overall yield in its cashew estates was affected due to abrupt shift to organic farming. But when I spoke to the managing director of PCK, he agreed that there had been an initial loss of productivity due to the increased attack of tea-mosquito bugs.

This is to be expected. Any shift to organic farming takes time, because a farm system must stabilize and adjust to the new interventions. During this time, pesticides should be made available for use as a last resort. But this didn’t happen in Kasargod. Research has shown that in cashew plantations, any shift to organic farming immediately causes a loss of yield of up to 50 percent before the system recovers. Clearly organic farming, for all its benefits, is no cakewalk.

To sum it up---there was a lot more to the endosulfan issue than what was reported by the Indian and global media. In taking its decisions, India was driven by fear and possibly misled by the political motivations behind the Stockholm Convention’s decision. What it should have done instead was carry out a high-quality epidemiological study of its own, evaluate the scientific evidence, and then taken a suitable decision. It could have been the same decision as it is today, but a more meaningful one.

Pesticides, Parkinson's and the Precautionary Principle

In May, two Italian scientists, Gianni Pezzoli and Emanuele Cereda, published a study in Neurology linking exposure to pesticides and solvents to Parkinson’s disease. I was immediately very curious. In my article “Kerala’s endosulfan tragedy---Did it really happen?”, I spoke about a very wide range of diseases being attributed to endosulfan exposure in Kasargod, Kerala. Among them was Parkinson’s Disease.

So what does this new study mean? Can we now say that all the people in Kerala receiving compensation for Parkinson’s are being classified correctly?

I emailed Cereda, one of the authors of the study, who was kind enough to respond.  This is what I understood. The paper, ‘Exposure to pesticides or solvents and risk of Parkinson’s disease’ is basically a meta-analysis of 104 past studies on pesticides. A meta-analysis is when you compare a number of different studies and hope to come across a trend you wouldn't have seen in an individual study.

What this study did was check if there was any correlation between occurrence of Parkinson’s disease and living in rural areas, consuming well water (likely contaminated by pesticides) and farming. And it found a significant link, although it isn't ‘conclusive’.

So does this mean endosulfan is likely to cause Parkinson’s? We still don’t know, because according to Cereda, 51 of the 104 studies were about exposure to a mix of pesticides. So the conclusion applies to people exposed to a mix of pesticides, and not any single one. We do not know which pesticides in this mix cause Parkinson’s, and it is highly likely that there is a group of 4-5 pesticides common to these 51 studies that are the culprits.

In Cereda’s study, there were only about 20 studies that linked specific pesticides to Parkinson’s.  Among these, exposure to Paraquat, a herbicide, caused a 2-fold increase in risk of Parkinson’s. On the other hand, no association was found with DDT, Maneb or Mancozeb.

This study, however, does not say what dose of exposure causes the disease. Cereda said this was the main limitation of his study, apart from the usual limitations of a meta-analysis.

In general though, this study goes much farther than previous studies in establishing a clear link between pesticide exposure and Parkinson’s.

Going back to the question I started with. Does this mean a chemical like endosulfan can cause Parkinson’s?  I guess we continue to remain in the same boat. There is a likelihood, but we can’t say for sure. The precautionary principle would come into play here, and farmers and people living in rural areas would have to reduce exposure to such pesticides.

On a related note, when the Royal College of Obstetricians and Gynaecologists (RCOG) issued guidelines this month to pregnant women, asking them to avoid chemicals in common household products such as cosmetics, sunscreen, air-freshener and plastic food containers, several scientists criticized the College for scaremongering, because, again, evidence of the endocrine disrupting properties of several of these chemicals is ‘inconclusive’.  There it is again. That dirty word.

One of the authors of the report, Richard Sharpe, however, defended the report, saying that if his wife was pregnant, they would be taking all those precautions.

I tried to contact some of the critics of RCOG’s report, but received no response.

Any opinions from readers on whether RCOG’s report amounts to scaremongering?

RedInk Award for Journalism 2013

A couple of days back, my article Flock Theory and the Synchronies of Nature won the first prize in the science and innovation category of the RedInk Awards for Journalism 2013. Obviously, I am quite pleased.

Kerala's endosulfan tragedy--Did it really happen?

Where I question the popular version of events in the global media

The Complex Problem of Developing Modern Drugs from Ayurveda

This post also appeared on Spicy IP 

In My Feb 2013 article in Open Magazine (read the complete story here), I researched why so few modern drugs had emerged from Ayurveda. For the many claims and research into Ayurvedic medicines that we come across, only a handful of modern drugs such as Reserpine have emerged from Ayurvedic leads. Reserpine, though, is a single molecule isolated from an Ayurvedic herb called Sarpagandha. Herbs in their natural form, such as Sarpagandha, Ashwagandha and Brahmi extracts, have no acceptance in modern medicine at all. They cannot be prescribed by modern-medicine practitioners as a cure for any disease, and can only be sold as dietary supplements. This means modern medicine does not accept the claims of Ayurveda. Why is this so? My article cited three reasons:

It is very tough to develop modern drugs from herbs. Herbs are complex mixtures of compounds and most modern drugs are single, pure compounds. Secondly, the quality of herbs varies from place to place and season to season. Finding the herb with the right potency is itself a major challenge. Then, one has to find the molecule in the herb that is causing the desired effect (in Sarpagandha, it was Reserpine). This is also a big challenge.

The odds have been stacked against traditional medicine because modern medicine took time to wrap its head around the mechanism of action of herbs. For a long time, the USFDA (United States Food and Drug Administration) required herbal drugs to undergo the same tests that synthetic drugs undergo to enter the markets. This means the active ingredient had to be identified for a herbal medicine to become a modern drug. This is difficult because many Ayurvedic drugs contain multiple active ingredients, and which one really works is often not established for years. Also, herbal mixtures vary from batch to batch during production---this presents a problem. How do you ensure that each patient receives a drug of the same potency and efficacy? Today, the USFDA has created new guidelines for herbal medicines. They need to provide lesser safety data, given their long history of safe use, and they need not establish the active ingredient. All this helps herbal drugs immensely.

In my story, I used the USFDA as a proxy for the modern medical stance. This is arguable, because countries such as Canada take a more lenient view of herbs, and yet, the FDA’s stance is fairly widespread. A number of Indian scientists I spoke to, such as Ram Vishwakarma of IIIM, talk of FDA requirements as a good standard to follow. They think Ayurvedic drugs should make an attempt to adhere to them. India, in comparison, has been too lenient towards the herbal-drug sector, not requiring any clinical trials for it. So, I couldn’t obviously use the Indian regulatory stance as a proxy for scientific acceptance.

India itself hasn’t done much to encourage herbal-drug development. Firstly, there are very few regulations for this sector, and Ayurvedic drugs don’t need to provide much scientific validation. Secondly, given the high failure rate in drug development, bodies such as India’s Department of Ayush ought to have encouraged extremely large-scale clinical trials and testing, as China has.

Instead, our herbal-drug development initiatives have been small and beset with duplication. Too many institutions are repeating the same work—the Department of Science and Technology, the Department of Biotechnology and so forth. This is partly why there are so many studies out there on Ayurveda, but put together---these don’t add up as conclusive proof of efficacy of the drug. The way to develop a drug is to pick up a single herb that shows activity and take it through the entire 10-15-year cycle of drug development. Instead people are doing disconnected research, which is widespread, but doesn’t help in validating Ayurvedic medicine.

According to Chittaranjan Andrade, who heads the department of psychopharmacology at Bangalore’s National Institute of Mental Health and Neurosciences, the only thing that matters at the end of the day is clinical trials. He says many herbal drugs seem to be very active in animal studies, but fail in humans. Andrade, who himself has carried out clinical trials on herbs with claimed central nervous system (CNS )effects, such as Ashwagandha, Brahmi and Shankhapushpi (which are prescribed for indications such as anxiety and poor memory), says no definitive clinical trial exists for any of these herbs.

Plus, some of the research out there is very unscientific. I had contacted the CCRAS, which is India’s apex body to promote Ayurveda, asking if the many trials published on their website, claiming miracle cures, were indeed placebo-controlled trials. Nobody responded. Later, many scientists told me off the record that those trials were of very poor quality. If this is the state of India’s apex Ayurveda-promoting body, how can we hope for better from the private sector?

CAN NON-DRUG INTERVENTIONS BE TESTED THROUGH PLACEBO-CONTROLLED CLINICAL TRIALS?

Having said all this---there were a few other points beyond the scope of the Open story that I’d like to bring up in this blog post. The Open story mainly discusses the subject of drugs, but Ayurveda is an entire system of medicine that entails lifestyle changes and non-drug interventions such as Panchakarma---a set of practices including purgation, massages, sweating, enemas etc.

One thing some of the scientists I spoke to wanted me to highlight was that Ayurveda should not be looked as a source of drugs alone. “Ayurveda is not just a ‘drug bank’…it has some very interesting concepts totally foreign to modern science,” says Venil Sumantran, adjunct professor in the department of Biotechnology at IIT Madras. These scientists say Ayurveda must be looked at for its method of diagnoses, its etiology, the way it views illnesses as holistic, and concepts such as the Tridosha classification.

This is an area that is as poorly researched as Ayurvedic drugs. Moreover, the gold-standard of clinical research---the double blinded, randomized, placebo-controlled clinical trial---probably doesn’t apply here. After all, how do you control a trial on Panchakarma for placebo? The patient knows exactly what treatment she is receiving, so you cannot ‘blind’ the trial either.

Further, Ayurvedic herbs are often administered along with such interventions. So the next question is---is it right to test Ayurvedic herbs in isolation?

The answer is yes. After all, Ayurvedic herbs do make specific claims about curing diseases, don’t they? If a herb claims to reduce anxiety in a patient, it should work in isolation, minus the lifestyle changes accompanying it. If it doesn’t, it must not be sold over-the counter, in isolation, which many Ayurvedic herbs are.

Secondly, we need to know if modern medicine has already created drugs better than these herbs. That needs to be tested, given how long it has been since the ancient Ayurvedic texts were written.

A sentence from a 1994 research paper by ethnobotanists Paul Alan Wilcox and Michael Balick about traditional medicine systems puts this in perspective. As ethnobotanists, Wilcock and Balick travel around the world, staying with ancient tribes and exploring their systems of medicine in an attempt to develop modern drugs from them. Talking about their investigations into herbs used by Samoan healers, Wilcox and Balick say, “We should note, however, that few of the compounds exhibiting activity in laboratory tests will become new drugs. Some will turn out identical to, or less potent than existing agents; others will prove too toxic for commercial use.”

This is really the key. The herbs described in Ayurveda may be potent---no one is denying that. But are they as potent as modern drugs used for the same indications? At the dosage levels they are potent enough, are they non-toxic?

The argument that all natural herbs have no side-effects is incorrect. Look at Veregen, for example, the first herbal treatment approved as a drug by the USFDA. It contains an extract of green tea, and like any other modern-drug, could have undesirable side effects such as redness, swelling, sores or blisters, burning, itching, pain (from the firm’s website). St John's Wort reduces the effects of several drugs, while compounding the effects of certain antidepressants such as SSRIs. Therefore, it is important to study the herb’s interactions with modern drugs too.

SHOULD HERBAL DRUGS BE SUBJECT TO DIFFERENT CLINICAL-TRIAL REQUIREMENTS?

There is another viewpoint among proponents of Ayurveda that I must highlight. This came from Dr Ashok Vaidya, who heads research at the Indian Council of Medical Research’s Centre for Reverse Pharmacology. He believes Ayurvedic herbs should not need to go through clinical trials the way modern medicines do. Why should an Ayurvedic drug firm have to spend $1bn going through the entire clinical-trial cycle when the safety of the drug is already proven, he asks?

He may have a point there.

After all, the FDA did publish guidelines for herbal drugs only in 2004, which made it easier to develop herbal medicines. Before this, not a single herbal medicine had been approved as a modern drug. The FDA did eventually realize that many of these medicines come with hundreds of years of safety data and so, maybe the process of herbal drug development could indeed be simplified further. Vaidya says certain clinical-trial phases relating to safety can be skipped. Clearly, Vaidya’s views are debatable at this point, and unless a regulatory body takes the call, journalists like me can’t really tell.

OIL AND WATER

Finally, another big problem with herbal-drug development is that, by and large, modern-medicine practitioners and Ayurvedic doctors don’t really talk to each other. This was the impression I received from several scientists. Some of the research personnel at IIIM Jammu spoke about how the Golden Triangle project failed because Ayurvedic doctors and scientists couldn’t reach common ground on the quality of herbal preparations to be tested.

This problem was also highlighted by Dr Bhushan Patwardhan, who headed several of India’s herbal-drug development programs under the National Millennium India Technology Leadership Initiative or NMITLI (see Open story). Even though no drug has emerged from this program, Patwardhan calls NMITLI a success because, for the first time, Ayurvedic doctors and modern scientists began talking with each other. According to him “Projects such as NMITLI should not be looked at from the product point of view. Its (NMITLI’s) most important deliverable was people. It was a great human-resource effort where scientists from the two sectors began talking to, working with and respecting each other. Earlier, they were like oil and water. NMITLI broke this wall; this was its most important achievement.” 

Afforestt and Miyawaki's Method

A company that plants forests

Why hasn't Ayurveda yielded modern medicines

An investigation into why Ayurveda hasn't yielded many modern medicines

Indians who won the Ignobel and their stories

Ignobel Indians

Theoretical scientists in ecology

On flock theory experiments by theoretical physicists