Clinical Trial

There’s Something You Really Need to Know About IV Vitamin ‘Shots’

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Want to boost your immune system, reduce your physical signs of ageing, or cleanse your blood to get rid of toxins? Intravenous (IV) vitamin therapy, or vitamin drips, promise to help.

Some claim they can even benefit serious conditions like cancer, Parkinson’s disease, the eye condition macular degeneration, the pain of fibromyalgia and depression.

Celebrities have promoted them on social media. The demand has led to alternative therapy lounges popping up around the world, including in Australia. Patients can kick back in comfy leather chairs while they’re hooked up to IVs in the infusion lounge, watch Netflix and have some tea.

But do they work? Or are you just paying for really expensive urine? Let’s look at what the science says.

What is IV vitamin therapy?

IV vitamin therapy administers vitamins and minerals directly into the bloodstream via a needle that goes directly into your vein. Fans of the therapy believe this enables you to obtain more nutrients as you avoid the digestion process.

Providers of these injections say they customise the formula of vitamins and minerals depending on the perceived needs of the patient.

Right now for example, many Australian lounges are offering drip “cocktails” containing immune boosting vitamins like vitamin C and zinc to help protect against the flu. Other popular therapy sessions come under names like “Energy Cocktail” and “Glow”. One vitamin IV therapy session can take 30-90 minutes and will cost between AU$80 to $1,000 (US$55 to $700).

Does IV vitamin therapy work?

IV therapy itself is not new and has been used in the medical profession for decades. In hospitals, it is commonly used to hydrate patients and administer essential nutrients if there is an issue with gut absorption, or long-term difficulty eating or drinking due to surgery.

Single nutrient deficiencies like vitamin B12 or iron are also often treated in hospital with infusions under medical supervision.

But the “cocktails” IV vitamin therapy clinics create and administer are not supported by scientific evidence. There have been no clinical studies to show vitamin injections of this type offer any health benefit or are necessary for good health.

In fact, there are very few studies that have looked at their effectiveness at all.

There is one review on the use of the “Myers’ cocktail” (a solution of magnesium, calcium, vitamin C and a number of B vitamins). But it just contains a collection of anecdotal evidence from singular case studies.

Another trial looked into the effectiveness of IV vitamin therapy in reducing symptoms of 34 people with the the chronic pain condition fibromyalgia. It found no significant differences between those who received the “Myers’ cocktail” once a week for eight weeks and those who did not.

In fact, the authors noted a strong placebo effect. In other words, many people said their symptoms improved when they were only injected with a “dummy” cocktail.

Another study that examined IV vitamin use in fibromyalgia patients was missing a placebo group, involved just seven patients and showed only short-term improvement in symptoms. The only other published study examined IV vitamin therapy use for asthma. But that study was of even poorer quality.

What are the risks of IV vitamin therapy?

Even when it comes to vitamins and minerals, you can have too much of a good thing. For example, if you take in more of the fat soluble vitamin A than you need, your body stores it, risking damage to major organs, like the liver.

IV vitamin therapy “cocktails” also often contain significant levels of the water soluble vitamins C and B. These are processed by the kidneys and excreted into urine when the body cannot store any more. This makes for some very expensive urine.

There is also the risk of infection with IV vitamin therapy. Any time you have an IV line inserted, it creates a direct path into your bloodstream and bypasses your skin’s defence mechanism against bacteria.

People with certain conditions like kidney disease or renal failure shouldn’t have IV vitamin therapy because they cannot quickly remove certain minerals from the body. For these people, adding too much potassium could lead to a heart attack.

People with heart, kidney or blood pressure conditions should also avoid IV vitamin therapy as there is risk of fluid overload without consistent monitoring. The consequences of fluid overload in these patients can include heart failure, delayed wound healing, and impaired bowel function.

What’s the bottom line?

For most of us, the quantities of vitamins and minerals needed for good health can be obtained by eating a healthy diet with a wide range of foods and food groups. Obtaining vitamins and minerals from your diet is much easier, cheaper, and safer.

Unless you have a medically diagnosed reason for getting a vitamin infusion and it was prescribed by your doctor, you are always better off obtaining vitamins and minerals through food. The Conversation

Emily Burch, Accredited Dietitian/Nutritionist & PhD Candidate, Griffith University.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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IPC identifies 17 medical device monitoring centres pan India to analyse SAEs exclusively

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To develop the culture of reporting of adverse events in healthcare institutions in the country, the Ghaziabad-based Indian Pharmacopoeia Commission (IPC) has identified 17 medical device monitoring centres pan India to analyse serious adverse events (SAEs) exclusively as part of Materiovigilance Programme of India (MvPI).

MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated in India.

This is a welcome change for the consumers and patients who are administered high risk medical devices like stents and implants as part of therapy in cardiac and orthopaedic disorders. Government has also been contemplating to introduce a high risk medical device registry to track SAEs due to faulty medical devices.

Uptil now SAEs have been reported through the Pharmacovigilance Programme of India (PvPI). Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 with Ghaziabad-based IPC as the National Co-ordinating Centre (NCC) to track adverse drug reactions (ADRs).

“Considering the fact that PvPI has filled the vacuum in reporting SAEs through its 270 ADR monitoring centres (AMCs) in the country, SAEs need to be intensively analysed in view of patient safety as devices are different from drugs which have a different shelf life. Medical device monitoring centres will do a dedicated job of reporting and analysing SAEs as envisaged in MvPI,” explains Dr V Kalaiselvan, principal scientific officer, IPC, Ghaziabad.

IPC has also set a mandate to set up a total of 300 ADR monitoring centres (AMCs) by 2020 as part of PvPI with focus on North Eastern (NE) states. It is in the process of identifying district hospitals in NE states which wish to participate as AMCs under the PvPI at district level.

“Besides this, we are strengthening and evolving various tools to report SAEs like the Medical Device Adverse Event (MDAE) reporting form,” added Dr Kalaiselvan.

The union health ministry in the past had mandated AMCs across the country to report SAEs due to medical devices as part of the MvPI.

The MvPI, being coordinated by the IPC at Ghaziabad, was launched in 2015. IPC functions as the NCC and Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health Systems Resource Centre (NHSRC) in New Delhi.

The purpose of the programme is to study and follow MDAE and enables dangerous ones to be withdrawn from the market.

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Experts Warn There’s a Huge Problem With How Mental Health Problems Are Diagnosed

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When creating a universal diagnostic tool for psychiatric illness, imperfection is inevitable. Now in its fifth edition, the widely-used ‘mental health bible’, known as the Diagnostic and Statistical Manual (DSM-5), has had a slew of controversies and some want to do away with it entirely.

As far back as 1968, experts have criticised the manual’s myriad flaws, arguing that its “disjunctive” categories are “unusable in a scientific context”. A detailed analysis of five key chapters in the current edition has now come to a similar conclusion.

Researchers from the University of Liverpool argue that today’s diagnoses for ‘schizophrenia‘, ‘bipolar disorder’, ‘depressive disorders’, ‘anxiety disorders’ and ‘trauma-related disorders’ are scientifically worthless as tools to identify these conditions.

Analysing chapters for these categories in DSM-5, the authors conclude that the manual’s rules are inconsistent and subjective, leaving a huge amount of overlap in symptoms between diagnoses.

The results mirror a study from 2014, which demonstrated that when using both the fourth and fifth edition, two people could receive the same diagnosis without sharing any common symptoms in the majority of cases.

That very same year, another team of researchers calculated that in the DSM-5 there are 270 million combinations of symptoms that would meet the criteria for both PTSD and major depressive disorder.

“This study provides yet more evidence that the biomedical diagnostic approach in psychiatry is not fit for purpose,” says co-author Peter Kinderman, a clinical psychology researcher at the University of Liverpool.

“Diagnoses frequently and uncritically reported as ‘real illnesses’ are in fact made on the basis of internally inconsistent, confused and contradictory patterns of largely arbitrary criteria.”

While flexible rules and pragmatic diagnoses allow psychiatrists to use ‘clinical judgement’, the authors think this system inevitably detracts from the rigorous and consistent criteria that come with discrete disorders. Psychiatric assessments often rely on the perspective of the observer, and oftentimes, they say, this judgement is “unambiguously ambiguous“.

Low mood, for instance, is seen as problematic only at a particular threshold, but this threshold remains undefined and the diagnosis is ultimately left to the clinician’s discretion. Meanwhile, other experiences like hallucinations are considered immediately ‘abnormal’ by their mere presence alone.

Such broad psychiatric brush strokes tell us very little about the individual experience and what evidence-based treatments they might need.

Growing evidence suggests that trauma or adversity is involved in the development of many psychiatric disorders, and yet even in DSM-5 there is no way to identify what a ‘normal’ or ‘appropriate’ response to such a severe stressor would entail.

As such, this diagnostic system wrongly assumes that all distress results from disorder, with limited reference to any experiences of trauma.

“In the case of the criteria for panic disorder,” the authors explain, “behaviour change related to panic attacks is constructed as unusual or unacceptable by what is described as ‘maladaptive’ criteria, despite this behaviour representing attempts to cope with the experience of panic attacks.”

The team further argues that labelling distress as abnormal could cause even more distress.

In the context of trauma, they use the example of flashbacks. These situations are already distressing enough as they happen, but the whole issue could be exacerbated if a natural response to them is regarded as abnormal.

As such, the authors suggest that psychiatrists could better find the cause of a person’s distress by allowing for individual experience, rather than “maintaining a commitment to a disingenuous categorical system”.

“Although diagnostic labels create the illusion of an explanation they are scientifically meaningless and can create stigma and prejudice,” says research psychiatrist Kate Allsopp.

“I hope these findings will encourage mental health professionals to think beyond diagnoses and consider other explanations of mental distress, such as trauma and other adverse life experiences.”

The research was published in Psychiatry Research.

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BIRAC invites proposals from Indian biotech cos for supporting affordable product/technology development

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The Biotechnology Industry Research Assistance Council (BIRAC) under its Small Business Innovation Research Initiative (SBIRI) scheme, has invited proposals from Indian biotech companies for supporting affordable product/technology development in the field of biotechnology from discovery to pre-commercialisation stage.

The programme supports industry for development of proof-of-concept and early stage validation of products/technologies. The eligible companies can send their proposals till July 31, 2019.

Major objectives of the SBIRI scheme are to provide support for early stage, pre- proof- of-concept research in biotechnology by industry; to support new indigenous technologies particularly those related to societal needs in the healthcare, food and nutrition, agriculture and other sectors; and to nurture and mentor innovative and emerging technologies/entrepreneurs, to assist new enterprises to forge appropriate linkages with academia and government.

SBIRI scheme of the Department of Biotechnology, Ministry of Science & Technology was launched in 2005 to boost Public-Private- Partnership (PPP) efforts in the country. SBIRI was the first of its kind, early stage, innovation focused PPP initiative in the area of biotechnology. Launching of SBIRI has worked as an enabling platform for the target organizations to realize their potential in terms of product and process development and taking them to the market. It has facilitated innovation, risk taking by small and medium companies and bringing together the private industry, public institutions and the government under one roof to promote the research and innovation in the Indian biotech sector. The projects supported under the scheme have resulted in prominent outcomes in the form of some products which have already come to the market and some promising research leads seeing ray of hope for commercialization.

As a unique institutional mechanism, SBIRI has consistently prioritized early stage funding for high risk innovative research in small and medium companies led by innovators with science backgrounds to get them involved in development of products and processes which have high societal relevance.

The SBIRI aims to strengthen those existing private industrial units whose product development is based on in-house innovative R&D; encourage other smaller businesses to increase their R&D capabilities and capacity; create opportunities for starting new technology-based or knowledge-based businesses by science entrepreneurs; and stimulate technological innovation.

A single or consortia of Indian company(ies), registered under ‘The Indian Companies Act 2013’ with minimum 51 per cent of Indian ownership, and in-house R&D unit, are eligible to apply for this programme, either alone or in collaboration with another company, institute or university.

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Australian Researchers Have Just Released The World’s First AI-Developed Vaccine

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A team at Flinders University in South Australia has developed a new vaccine believed to be the first human drug in the world to be completely designed by artificial intelligence (AI).

While drugs have been designed using computers before, this vaccine went one step further being independently created by an AI program called SAM (Search Algorithm for Ligands).

Flinders University Professor Nikolai Petrovsky who led the development told Business Insider Australia its name is derived from what it was tasked to do: search the universe for all conceivable compounds to find a good human drug (also called a ligand).

“We had to teach the AI program on a set of compounds that are known to activate the human immune system, and a set of compounds that don’t work. The job of the AI was then to work out for itself what distinguished a drug that worked from one that doesn’t,” Petrovsky said, who is also the Research Director of Australian biotechnology company Vaxine.

“We then developed another program, called the synthetic chemist which generated trillions of different chemical compounds that we then fed to SAM so that it could sift through all of these to find candidates that it thought might be good human immune drugs.”

The team then took the top candidates SAM identified, synthesised them in a lab and tested them on human blood cells to see if they would work.

“This confirmed that SAM not only had the ability to identify good drugs but in fact had come up with better human immune drugs than currently exist,” Nikolai said.

“So we then took these drugs created by SAM into development with animal testing to confirm their ability to boost influenza vaccine effectiveness.”

Petrovsky said this potentially shortens the normal drug discovery and development process by decades and saves hundreds of millions of dollars.

The research received funding from the US National Institute of Allergy and Infectious Diseases – part of the country’s National Institutes of Health (NIH) – and has begun 12-month clinical trials across the US.

“We already know from animal testing that the vaccine is highly protective against flu, outperforming the existing vaccines. Now we just need to confirm this in humans,” Petrovsky said.

The new vaccine comes at the same time as a high number of influenza-related cases in Australia. Before June 2019, 228 people had died from flu related complications, including 57 people in New South Wales and 48 people in Victoria.

Associate Professor Dimitar Sajkov highlighted the need for a better flu vaccine after a number of influenza sufferers this year had already received the 2019 flu vaccine.

“It is tremendous to see such a promising vaccine that we developed with the very first human trials being done at Flinders, progressing onto the world stage,” he said in a statement.

“So far in 2019 there have been over 96 thousand confirmed cases across Australia. The number in WA nearly doubled to 10 thousand, as did the number of deaths, there have been 57 deaths recorded in NSW, 44 in SA, and nearly 40 in Queensland.”

Petrovsky hopes this vaccine will prove to be more effective than the existing vaccines and will go on to complement or replace them as the standard seasonal flu shot.

“If this is the case then the same technology we are using for flu vaccines can be applied to improve or develop many other vaccines,” he added

It’s not the first time that Flinders University has had a breakthrough in the vaccine department. In 2009, the team was the first to develop a swine flu vaccine.

Where’s the money?

Despite the groundbreaking work the Flinders University team completed, Petrovsky said it’s challenging to receive funding for new vaccines in Australia.

“Australia has a great record at publishing basic medical science and has a poor track record of developing new drugs or treatments,” he said.

“(But) funding bodies in Australia like NHMRC (The National Health and Medical Research Council) direct the vast majority of their funding to the “big end of town”, i.e. the large research institutes.

This makes it very difficult for researchers based outside the large institutes or the biggest universities to compete and get research funding. It is particularly difficult for hospital-based researchers like ourselves to get any traction in this system, despite the fact that past Nobel prizes including Barry Marshall‘s came out of hospital-based research.”

Such a situation means local researchers are often forced to go overseas.

“As an act of desperation, I took a grant application rejected by NHMRC and submitted it to the US NIH (National Institute of Health) as a last-ditch attempt to save my career in research. Much to my surprise and joy, the original US grant application was successful, allowing my research to survive.”

Petrovsky has since received more than 10 NIH grants and supplements totalling more than US$50 million. He said that even by US standards, it was an “extraordinary outcome”.

“I think this is because the US system values ambitious, innovative and futuristic research whereas Australian funding bodies are highly conservative and only fund me-too incremental research where the outcome is largely already known,” he said.

An NHMRC spokesperson told Business Insider Australia in an email: “Funding applications for health and medical research projects are subject to rigorous, expert peer review against published criteria, to ensure transparency, probity and fairness.

“Therefore only applications – including applications for the development of flu vaccines – of the highest quality are funded by NHMRC.”

This article was originally published by Business Insider.

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