There’s a Reason Probiotics Do Very Little – But a New Type of Pill Could Change That

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Probiotics – pricey supplements designed to support the trillions of bacteria blossoming in our guts – have become a big business, with a market that is projected to exceed US$57 billion in the next five years.

“Probiotics are probably the single most important new food category to emerge in the last 20 years,” Scott Bass, the head of the Global Life Sciences team at law firm Sidley Austin LLP and an adviser for the FDA on its first dietary supplement website, told Business Insider.

The idea behind the pills is simple: foster the growth of beneficial bacteria in the gut and curb the growth of the bad bacteria to improve digestion, boost the immune system, and even lower rates of certain diseases.

Putting that idea into practice, however, has proven a bit more complicated than some scientists initially envisioned.

So far, the effects of existing probiotic supplements have been all over the map – sometimes they help, but most of the time, they don’t.

Nevertheless, supplement-makers continue to advertise their pills as beneficial for everything from weight loss to treating lactose intolerance.

The problem is that while most probiotic formulas contain tens of millions of beneficial bacteria, like Lactobacillus acidophilus, fewer than a hundred or so of those bacteria actually make it into your gut.

“Thirty billion Lactobacillus sounds good, but after going through the stomach acid, only about 43 of them survive,” Ian Orme, a distinguished professor of microbiology and pathology at Colorado State University, told Business Insider.

These “good” bacteria are supposed to replace the “bad” bacteria (like Bifidobacteria) and help you feel better.

“In other words these 43 or so bacteria politely ask the million or so anaerobic Bifidobacteria to please leave,” said Orme. “Yeah, sure.”

There are some specific incidences where the research suggests that the pills could actually help.

A rigorous 2014 review of probiotics research concluded that the supplements could be especially helpful for newborns with intensive needs.

Adding “good” bacteria to the guts of infants at risk of developing the life-threatening gut disease necrotising enterocolitis, for example, significantly reduced the chances that they’d come down with the disease.

More recently, researchers have been experimenting with supplements called synbiotics, which combine a probiotic bacterial strain with what’s called a prebiotic – essentially a type of sugar designed to feed the beneficial bacteria and help it thrive in the gut.

The idea is that the pre- and the pro-biotic would work together to provide a combined benefit – while the probiotic settles in and pushes out the “bad” bacteria, the prebiotic hangs around and acts as its food supply, ensuring that the supplement sticks around and does its job.

Just this month, as part of the first large-scale clinical trial of its kind, researchers working in rural India found that newborns who were given a synbiotic were at a substantially lower risk of developing sepsis, a potentially fatal condition characterised by severe infection.

Some small studies have suggested that synbiotics could provide benefits to a range of other conditions influenced by the gut microbiome as well, including obesity, diabetes, and non-alcoholic fatty liver disease, but larger-scale clinical trials focusing on each of those conditions are needed.

So if you see a probiotic – or a synbiotic – for sale at your local health-foods store, know that the existing research backing up its claims is very limited.

This article was originally published by Business Insider.

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AMTZ signs MoU with IIT Bombay to boost innovation in medical device industry

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The Andhra Pradesh MedTech Zone (AMTZ), which is setting up India’s first ultra-modern medical equipment manufacturing park in Visakhapatnam, has signed a Memorandum of Understanding (MoU) with the Indian Institute of Technology, Bombay (IIT-B) for accelerating medical device innovation and commercialization within the country.

Signed between Dr Jitendar Sharma, CEO, AMTZ and Prof. Petety V Balaji, Dean, R&D, IIT Bombay, the MoU will enable manufacturers at AMTZ with access to laboratories, training programs and talent from IIT Bombay. New product development, research, government policy promotion will also receive a boost with this partnership between industry and academia.

Startups in the field of medical technology which are part of the IITB incubator programme will also benefit from the large integrated ecosystem being provided by AMTZ. This partnership will contribute positively towards the development of the overall medical technology ecosystem in the country.

AMTZ would include facilities such as component testing centre, electro-magnetic interference laboratory, medical grade low vacuum molding, cabinet molding, injection molding centres, 3D designing and printing for medical grade products,
sterilization and toxicity testing centre, radiation testing centre, gamma irradiation facility, rapid prototyping centre, warehousing and regulator’s office.

AMTZ which is India’s first Government funded medical device park is today serving as a one-stop- solution for not only reducing cost of manufacturing up to 40% and to simplify end-to- end operations but also reducing import dependency, which is presently around 75%.

AMTZ also has the distinction of becoming the second Indian park to become a full-time member of the International Association of Science Parks and Areas of Innovation (IASP). With AMTZ becoming a member of IASP, new business opportunities for companies and research organisations located within AMTZ and in Andhra Pradesh will be enhanced. This will also be a boost for development and growth of areas of innovation.

IASP is a membership-based global network for science parks and areas of innovation to drive growth, innovation and effectiveness. Headquartered at Málaga, Spain, IASP is headed by Josep Miquel Piqué as its President and Luis Sanz as the Director General.

Incorporated on 30 April 2016 and foundation stone laid on 19 August 2016, AMTZ is an enterprise under the Government of Andhra Pradesh, a 270 acre zone, dedicated for medical device manufacturing.

Dr. Jitendar Sharma, Director, AMTZ said, “AMTZ has become the first scientific park in the state and the second in the country to become a member of IASP which is a unique achievement of its kind.” This membership complements the approval of Kalam Institute of Health Technology, which AMTZ received recently.

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This Powerful New Painkiller Could Be The Unexpected Ticket to Replacing Opioids

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Researchers have developed a new class of pain relief that acts on an obscure nerve pathway, opening the way to a medication just as concerns have deepened around the US opioid addiction and overdose epidemic.

While any marketable pharmaceutical based on the discovery would still need to go through the long process of clinical testing, the compound appears to work as well as other opioid-alternatives, requiring a smaller dose and remaining effective for a longer period.

The research led by scientists from The University of Texas has identified a group of molecules that bind with a pair of nerve receptors, one of which has been a mystery until recently.

The sigma-one receptor protein (σ1R) has been recognised as a potential target for a variety of therapeutic medications for well over a decade, with various drugs blocking or activating this important receptor on the membranes inside nerve cells.

But a sister receptor called sigma 2 receptor (σ2R) has remained rather enigmatic. Discovered a quarter of a century ago, it was only this year that researchers published details on the gene that coded for the protein, officially identifying the receptor as transmembrane protein 97 (Tmem97).

Both σ1R and σ2R/Tmem97 were considered promising candidates for pathways that could be exploited to treat pain that arises from damaged nerves, a condition referred to as neuropathy.

Around 20 million people in the US alone suffer from the symptoms of nerve pain, which in mild cases is managed by over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin.

For those suffering chronic pain, choices are a little more limited.

Opioids can do the trick, but come at a cost as doses need to increase with time in order to achieve the same level of relief. Many people are also allergic to this family of pain relief.

A non-opioid drug called gabapentin, sold under the brand name Neurontin, is often used to manage neuropathy. While its mechanisms aren’t all that clear, it’s thought to be involved in the regulation of the neurotransmitter gamma-Aminobutyric acid, or GABA.

Of the compounds being researched in this latest study, three that activated σ2R/Tmem97 appeared to reduce discomfort in mice that had spinal nerve pain.

“We started out just working on fundamental chemistry in the lab,” says researcher James Sahn.

“But now we see the possibility that our discoveries could improve the quality of people’s lives. That is very satisfying.”

One of the compounds called UKH-1114 alleviated pain at one-sixth of the dose of gabapentin and peaked in its effectiveness at 48 hours, rather than lasting just 4 to 6 hours.

Clinical trials would still be needed to establish its effectiveness, dosages, and any potential side effects in humans, but early signs are promising.

“This opens the door to having a new treatment for neuropathic pain that is not an opioid,” says Stephen Martin from The University of Texas.

“And that has huge implications.”

The current crisis in the US over the prescription and use of both legal and illicit opioids has recently been declared a federal state of emergency, as lives are lost as a consequence of addiction. Recent CDC estimates put US deaths at over 90 every day.

The high levels of opioid prescription could be considered a contributing factor, though the solution is far more complex than simply depriving people from necessary medication.

Finding suitable replacements to opioids might not eliminate the problem, but would certainly provide a wider range of options.

Earlier this year a compound called RgIA was derived from the venom of cone-shell molluscs, offering yet another possibility in the arsenal of pain-fighting compounds.

With more work to unravel the workings of σ1R and σ2R/Tmem97 receptors, we could see a whole new family of pharmaceuticals bring relief for millions who live with crippling pain and the risk of addiction every year.

This research was published in PNAS.

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Poor implementation of online tracking of drugs at ports hits industry badly

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Ever since the government has introduced online system to track imports of drugs at ports a couple of years ago, the online system named Icegate system has been marred by procedural flaws leading to its poor implementation which has badly impacted the industry.

It is learnt that after two years of its introduction, the system is not completely online and the bill of entries are being accepted off line too leading to delays, inconsistent decisions and poor tracking of data related to drugs.

This change in procedure has led to non-uniformity in procedure and hence delays in release of products and added cost to the importer as demurages which has impacted the trade.

Demurrages refers to the charges that the shipowner pays to the charterer for its delayed operations of loading/unloading. Officially, demurrage is a form of liquidated damages for breaching the laytime as it is stated in the governing contract (the charter party).

The custom house agents are supposed to file bill of entries online and get clearances online as per the Icegate system. If the consignment is drug it requires on line clearance from assistant drug controller (ADC) before getting clearance from the customs department as per the online system.

Recently, Drug Controller General of India (DCGI) has also written to the Commissioner Information Technology (IT) Customs to look in the matter and make the system consistent so that the monitoring of drugs being imported is uniform throughout the country.

As per sources, drugs released without ADC NOC may be risky and Icegate system was introduced for drug imports on insistence of the Prime Minister’s Office (PMO) only to mitigate that risk. Commerce ministry and Health ministry therefore need to address this issue so that only online system is adopted completely for release of drugs in the country.

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Scientists Are Finally Set to Mass-Produce The Active Compound Found in Magic Mushrooms

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For nearly 60 years scientists have known the chemical responsible for magic mushrooms’ psychedelic reputation is a compound called psilocybin. What we haven’t known is the biochemical pathway behind this famous hallucinogen.

Feel free to now tick that one off your chemistry bucket-list. German researchers have identified four key enzymes involved in making the chemical, potentially setting the stage for mass production of a promising pharmaceutical.

Psilocybin was first identified by the Swiss scientist Albert Hofmann way back in 1959, but has only recently re-entered the spotlight as a safe way to treat conditions related to anxiety, depression, and addiction.

As the evidence mounts, there could be a need for an efficient way to synthesise the compound for experimentation and mass production.

So a small team of researchers from Friedrich Schiller University Jena in Germany sequenced the genomes of the magic mushroom species Psilocybe cubensis and Psilocybe cyanescens to hunt for the biochemical components responsible for constructing this mind-bending molecule.

They had their suspicions, as early work on the molecule’s biosynthesis using radioactive tags had already revealed the order of the steps required to turn a molecule of tryptophan – an essential amino acid – into a series of chemicals, ending up with psilocybin.

While the order is a little different than it first appeared, it turns out four enzymes are responsible for the entire process.

Knowing what these enzymes are as well as the genes that encode them is a boon for any future pharmacologist who might want to churn out buckets of the stuff, or tweak the secret recipe to suit their needs.

“Our findings set the stage for heterologous production of [psilocybin] in a controlled place for pharmaceutical purposes, using engineered microbial hosts, should the re-discovered pharmaceutical value lead to increased demands,” the researchers write in their report.

Unfortunately since the mid 1960s, the production of psilocybin from mushrooms has been heavily regulated, with a reputation as a mind-altering drug for party-goers rather than a potential therapeutic for mental illnesses.

That not only made it harder to study, its baggage as an illicit substance has dissuaded researchers from looking deeper into any potential benefits.

After four decades of virtually ignoring the science of psychedelics, researchers tentatively returned to investigating how substances such as lysergic acid diethylamide (LSD) and psilocybin behaved in the brain.

Since then researchers have found evidence that psychedelics can reduce the clinical symptoms of mood and affective disorders, addiction, and even help painful conditions such as cluster headaches.

More recently, it’s been found that small doses of psilocybin can be used in conjunction with therapy to help ‘reset’ brains as they’re going through counselling.

As far as risks go, the biggest problems consumers of magic mushrooms currently face stem from mistaking their mycology and picking a toxic dead ringer in the wild, finding specimens that have too little (or too much) active compounds for their liking, or behaving in dangerous ways under the drug’s influence.

“Magic mushrooms are one of the safest drugs in the world,” consultant addiction psychiatrist Adam Winstock recently told Olivia Solon at The Guardian.

Compared with other illicit substances such as LSD, cocaine, and MDMA, risk of harm from taking psilocybin is at least five times lower.

For all of its promise, even the most advanced clinical trials won’t bear fruit for a number of years.

If, or when, psilocybin gets the big tick of approval as a safe and effective form of medication, it’s nice to know the groundwork has been set for a cheap and effective production process.

This research was published in Angewandte Chemie.

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