The results of newly-released research suggest that long-term opioid back pain treatments are linked to a raised erectile dysfunction risk.

The study appears in 15 May's 'Spine' publication and is reportedly the first of its kind to draw on electronic health data.

The research was lead by Richard A Deyo who, with his colleagues, looked at more than 11,000 men's medical histories. Deyo and his team began their study with the knowledge that men who experience chronic pain can develop erectile dysfunction as a by-product of age, smoking or depression. They also launched it on the premise that, while the erectile dysfunction factor is acknowledged, its prevalence among back pain sufferers hasn't previously been too clear.

Therefore, they obtained 11,327 medical records with several things in common: all the men lived in either Washington or Oregon, all were signed-up to the same health plan and all had made a doctor's visit in 2004 while experiencing back pain.

Opioids: Erectile Dysfunction Link

The researchers went six months either side of these men's doctors' appointments, in search of opioid drugs and/or erectile dysfunction treatment prescriptions. Ultimately, they discovered that men who took high opioid drug doses (equivalent to 120 daily milligrams of morphine) on a long-term basis (four months-plus) were twice as likely to need erectile dysfunction treatments than men not taking these drugs.

They also established that approximately 19 per cent of the long-term opioid users had at least some experience of erectile dysfunction, warning that the real total might be higher still. "That could well be an underestimate, because many don't bring it to their doctors attention, would be embarrassed or wouldn't connect it to medication", Deyo explained in comments made to Fox News.

Data released by the US CDC (Centers for Disease Control and Prevention) shows that, during the period 1999-2010, there was a massive, four-fold surge in opioid drug prescriptions issued in the United States.

Scientists have created a "magic bullet" nanomedicine that could become the first treatment for patients suffering with Acute Lung Injury (ALI).

At the moment, there are no effective treatments for this severe condition, which can result in breathing problems and fluid-filled or inflamed lungs. In the UK, there are 15,000 cases of AFI each year, which can become fatal due to lung failure.

But two schools at Queen's University in Belfast - the Centre for Infection and Immunity and the School of Pharmacy - have collaborated to develop a new medicine that could help change this.

Measuring about one billionth of a metre, their new drug is known as a nanoparticle. This means the patient, drawing the medicine directly to the inflammation point in the lungs, can inhale it.

Benefits Over Current Treatments

Existing treatments cannot directly target the inflammation and can also cause unpleasant side effects.

If the team's drug proves successful, the nanoparticle could also be used as treatment for other common lung disorders including Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD).

Research leader from the School of Pharmacy, Professor Chris Scott, said the majority of research in this area centers on how drug delivery to the disease location can be enhanced in these tiny carriers.

"Our own research in this area focuses on how nanoparticles interact with cells and how this can be exploited to produce therapeutic effects both in respiratory disease and cancer," he said.
Queen's new nanoparticle contains a surface allowing it to identify and bind to immune cells known as macrophages within the lungs - which is imperative to the uncontrolled inflammation occurring in ALI.
This binding rapidly reduced the inflammation, and could potentially prevent the harmful effects that would otherwise ensue in ALI patients' lungs.

Possible Treatment of Cystic Fibrosis

The disease affects a fifth of all patients in intensive care, and ALI sufferers often need ventilators to help their breathing. Beds with such equipment cost the NHS more than £1,800 each day, so the new medicine could considerably reduce costs.
The project will develop the nanomedicine towards clinical evaluation over the next three years, and at the moment is funded by a two-year £505,000 sponsorship grant from the Medical Research Council Developmental Pathway Funding Scheme.

Indian scientists have launched a new, affordable anti-rotavirus vaccine named 'Rotavac', which has performed impressively in recent trials.

Rotavirus is lethal and it claims the lives of an estimated 500,000 children every single year. According to the Rotavac vaccine's developers, the new product has the potential to reduce this annual total by thousands.

Rotavirus protection vaccines are already available from Merck and GlaxoSmithKline but, in India, they cost approximately 1,000 rupees per dose. In contrast, Rotavac is priced at 54 rupees per dose: a factor that ought to support its planned wide-spread distribution.

Rotavirus Protection Vaccine

Rotavac is manufactured by Bharat Biotech - a pharmaceutical company based in Hyderabad. So long as the new rotavirus protection vaccine is approved by regulators - a stage expected to have been reached by early 2014 - Bharat Biotech has said it'll be able to put Rotavac into mass production.

"This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year", stated K Vijay Raghavan - an official at the Indian Department of Biotechnology. "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India."

Rotavac

Rotavac has been in development for over two decades. It began life as an isolated rotavirus strain obtained from one child. Since then, a large number of organisations have become involved in the programme. They include the US Centers for Disease Control and Prevention, Stanford University School of Medicine and the US National Institutes of Health.

The Rotavac vaccine Phase III clinical trials involved almost 7,000 infants, all aged between six and seven weeks when they first enrolled.

"With its low price and strong efficacy, Rotavac has the potential to significantly reduce the incidence of severe diarrhoea due to rotavirus among children in India", said Doctor M K Bhan.

"Vaccines work to save and protect children from diseases like rotavirus for a lifetime", added Bill & Melinda Gates Foundation Co-Chair, Bill Gates. "This public-private partnership is an exemplary model of how to develop affordable technologies that save lives."

Rotavirus mage copyright Dr Graham Beards - Courtesy Wikimedia Commons

Leading Indian drug manufacturer Ranbaxy Laboratories has been ordered to pay a history-making $500m fine.

Set higher than any fine previously given to a generic drug production firm, the $500m fine relate to lies and sub-quality generic drug manufacturing and distribution processes.

Ranbaxy USA - Ranbaxy Laboratories' US division - admitted that it improperly made, stored and tested its drugs. This admission was the culmination of a lengthy investigation, which lasted 12 months. On top of this, Ranbaxy USA also said it had falsified drug test data.

Ranbaxy Fine

According to the prosecutors who delivered the historic Ranbaxy fine, the drugs involved in the case included an antibiotic in generic form and various acne, nerve pain and epilepsy treatments.

No evidence has emerged to suggest that Ranbaxy's drugs were the trigger for any health issues. However, Ranbaxy USA was found to have violated the Federal Food, Drug and Cosmetic Act, banning impure drugs sales. The enquiries made into its methods represented just one element of a wider generic drug investigative campaign.

Generic Drugmaker Fine

"While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy's stakeholders; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance", commented Arun Sawhney - CEO of Ranbaxy USA.

Supplementing the trailblazing generic drugmaker fine, Ranbaxy has now allocated an extra $500m sum to be used in the event that it's ordered to pay future fines.

Ranbaxy has also confirmed that it cooperated at every stage of the investigation and that, in times ahead, it anticipates "future growth in the US and around the world, with a robust pipeline of new products."

Image copyright Ezran Kamal - courtesy sxc.hu

GlaxoSmithKline has teamed up with Save the Children to produce drugs capable of lowering Sub-Saharan Africa's child mortality rates. Together, the two organisations are aiming to save one million lives but, already, the plan's been criticised by those concerned about a major pharmaceutical firm and a charity teaming up in this way.

Save the Children has recognised this view but asserted that the programme will, literally, be a lifesaving initiative. According to Sir Andrew Witty, GlaxoSmithKline's chief executive, it's a "groundbreaking partnership" which sees "both organisations working in genuinely new ways to save the lives of a million children."

As it works to accomplish this, GSK intends to modify some members of its existing pharmaceuticals family to suit the task in hand. For example, chlorhexidine - an antiseptic featured in the company's Corsodyl mouthwash - will be reconfigured so it can clean a newborn baby's umbilical cord attachment area and thereby stop infection taking hold.

One Million African Lives

The firms' one million African lives initiative will also involve a soluble antibiotic anti-pneumonia drug project and a malnutrition treatment and in all cases, the medicines will be made available at cost price. GSK especially makes the point in its press release that, in Sub-Saharan Africa, pneumonia is a leading cause of death among under-five-year olds.

Two nations will be focused-on at first - Kenya and DR Congo - and other countries will be incorporated in due course.

GSK and Save the Children

"In the past Save the Children may not have embarked on a collaboration with a pharmaceutical company like GSK", Save the Children's Justin Forsyth admitted. "But, we believe we can make huge gains for children if we harness the power of GSK's innovation, research and global reach."

"At GSK, we are motivated by developing innovative life-saving medicines and getting them to the people that need them", Sir Andrew added. "By joining forces with Save the Children, we can amplify these efforts to create a new momentum for change and stop children dying from preventable diseases."

Image copyright USAF - Courtesy Wikimedia Commons

A toxic spider venom protection vaccine could soon be in development, thanks to research recently carried out in Brazil.

The Brazilian scientists involved produced a synthetic protein effective enough to safeguard rabbits against the effects of Loxoscelism: a condition for which there isn't currently an approved drug treatment.

Loxoscelism occurs as a result of being bitten by a spider from the Loxosceles group, of the type that, in 2012, caused nearly 7,000 injuries just in Brazil. Loxosceles spiders are found in locations around the world and they include the brown spider. Those they bite can expect to develop open sores and, in some cases, start bleeding on the inside.

Anti-Spider Venom Vaccine

The anti-spider venom vaccine team incorporated some of the venom into their protein mix and then gave it to the rabbits. According to the scientists, no skin damage occurred at the sites where the protein entered their bodies and there was no internal haemorrhaging reported, either.

"In Brazil we see thousands of cases of people being bitten by Loxosceles spiders, and the bites can have very serious side- effects", explained Doctor Carlos Chávez-Olortegui from Brazil's Universidade Federal de Minas Gerais.

"Existing anti-venoms are made of the pure toxins and can be harmful to people who take them. We wanted to develop a new way of protecting people from the effects of these spider bites without having to suffer from side-effects."

Spider Venom Protection Vaccine

Now, it's envisaged that the scientists' preliminary work could be the springboard towards next-generation spider venom protection vaccines, with the potential to save thousands of lives each year.

"It's not easy taking venom from a spider, a snake or any other kind of venomous animal", Carlos Chávez-Olortegui added. "With our new method, we would be able to engineer the proteins in the lab without having to isolate whole toxins from venom. This makes the whole process much safer."

Statin drugs designed to lower cholesterol and taken by millions of the world's residents could also lower kidney cancer-related mortality levels, according to new findings.

Previous medical research has already linked the likes of Zocor, Lipitor, Pravachol and Crestor to a reduced cancer development risk. Now, it seems the same drugs are capable of taking on renal cell carcinoma: a particular type of kidney cancer.

The message was delivered to those present yesterday at the American Urological Association's yearly conference. "Given that one in four Americans over 45 years of age take a statin and renal cell carcinoma occurs most often in men ages 50 to 70, it may be prudent to prospectively evaluate if statins protect against [cancer] progression", the University of Chicago's Doctor Scott Eggener - who headed this research - explained in a statement made there.

Statin Drugs: Kidney Cancer Research

The statin drugs kidney cancer research involved some 900 patients, all of whom had undergone renal cell carcinoma surgery between 1995 and 2010.

From analysing these kidney cancer patients' medical histories, several telling statistics emerged. Among those patients not taking statins, there was a 17 per cent death rate. However, among patients on statins, the death rate was seven per cent lower, at 10 per cent.

Once they'd taken other factors into account, Eggener and his colleagues established an solid association between statins use and increased kidney cancer patients survival.

"Last year, in a study published in the New England Journal of Medicine, Danish researchers studied 13 different cancers and found that in all types, the use of statins was associated with longer cancer specific survival", commented urology export Doctor Manish Vira.

"Given the current data and known cardiovascular protective effects of statins, certainly it seems prudent to design clinical trials to study the potential of statin therapy in breast, colon, prostate and now kidney cancer treatment."

Inexpensive antibiotics could be the cure for millions of people suffering from back pain - for ever.

Last night, experts acclaimed the miraculous cure that would save patients from costly, major surgery.

Danish researchers discovered that up to 40 percent of chronic pain in the lower back is a result of bacterial infections. This means that an intensive antibiotics course could be the rescue for nearly half of the people suffering from the condition.

One of the most distinguished spinal and neurological surgeons in Britain described the breakthrough as the greatest he had observed, and Nobel prize-worthy.

Antibiotics Treat Back Pain

The University College London Hospital's Peter Hamlyn said, "This is vast. We are talking about probably half of all spinal surgery for back pain being replaced by taking antibiotics."

He added that the repercussions of this could not be exaggerated, that it is a massive breakthrough.

Surgery is extremely expensive, he said. While the procedure costs thousands of pounds for every patient, the antibiotics only costs £114 - representing both an effective and incredibly inexpensive alternative.

At the moment, the UK's National Health Service spends a minimum of £480 million annually on back surgery, with most aimed at pain relief.

The £114 100-day antibiotics treatment could shortly be available for people in the UK.

Mr Hamlyn said that £250 million could be wiped from the NHS budget by eradicating unnecessary operations.

Dr Hanne Albert at the University of Southern Denmark has been working on the research for the last decade. The lead scientists and his team identified a pathogen that can be diagnosed via an MRI scan, and is accountable for a large number of chronic lower back pain cases.

Published in the European Spine Journal, the team's findings showed that 80 percent of patients during trials who had been afflicted with the condition for over six months were pain free following a course of antibiotics.

The alternative would have been undergoing extreme surgery in order to remove the damaged and infected tissue.

At least four million Britons suffer from debilitating back pain during their lifetime, and around three million go to their GP with the symptoms every year.

A drug warning's gone out from the US Food and Drug Administration to pregnant mothers. In it, the US FDA advises those who experience migraines to avoid drugs with a valproate content, since their children's future IQ scores might suffer as a result.

Consequent to the FDA's valproate child IQ damage warning, drugs that feature this ingredient will get updated labels, supplementing text already in place that links valproate to potential birth defects.

Valproate is a part of Depacon (valproate sodium), Stavzor (valproic acid) and other medications, plus their generic variations.

Previously, the FDA had approved valproate drugs for several conditions including epileptic seizure and bipolar disorder treatment, along with migraine prevention. However, more recently, valproate's effects had been assessed in a study. The results of this study revealed that the children of mothers who had taken valproate drugs produced significantly lower IQ test results than children whose mothers avoided these drugs during pregnancy.

FDA Valproate Warning

The US FDA valproate warning states that, since the women involved took the drugs from the start to the end of the pregnancies, it can't be determined whether there's a peak time for valproate to take effect. It adds that, while valproate might be a viable epileptic seizure and bipolar treatment, it should be a secondary choice for pregnant women, after other options have first been explored.

In addition: "Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use", said Russell Katz MD from the FDA's Center for Drug Evaluation and Research.

The FDA also cautions 'women of childbearing age' to employ birth control measures if they're taking any products containing valproate and advises those who become pregnant to seek immediate professional healthcare advice.

Image copyright Wong Mei Teng - Courtesy sxc.hu

With funding supplied by Canada, a long-established antidepressant is being trialled in Uganda as a fungal brain disease treatment drug.

Launched by Pfizer at the start of the 1990s, sertraline - marketed as Lustral or Zoloft - is now off-patent and remains a hugely widely-prescribed drug. Besides its antidepressant properties, sertraline is also very good at tackling infections, as confirmed during a recent trial conducted by the University of Utah.

Now, Uganda's Infectious Disease Institute is seeing what the drug can do for cryptococcal meningitis patients: those with a condition that kills 600,000 people in Sub-Saharan Africa every single year.

Sertraline Cryptococcal Meningitis Treatment

Those involved in the sertraline cryptococcal meningitis treatment programme hope to reduce that current fatality rate by up to 50 per cent.

Presently, Ugandan cryptococcal meningitis patients get prescribed either amphotericin or flucytosine. These are both comparatively elderly drugs that, in Uganda, aren't cheap or easy to obtain. The goal, then, is to deliver to the Sub-Saharan cryptococcal meningitis population a more affordable and widely-available option.

Another key factor in sertraline's favour is its history: as an already-approved and marketed drug - subject to further testing and approvals - it's well-ahead of any new drug developed for the task in hand. In addition, it's off-patent and, so, able to be manufactured and marketed generically, reducing its costs even further.

Ugandan Meningitis Drug Trial

Canada's involvement in the Ugandan cryptococcal meningitis drug trial comes via the Grand Challenges Canada project, though which it's invested $100,000 into the venture. Grand Challenges Canada also involves over 100 other health-based investment programmes implemented (or being implemented) in a total of 13 undeveloped nations.

"We're hoping to teach an old drug new tricks", Infectious Disease Institute representative David Meya, who's leading this project, told news agency AFP. "Our hope is that if this drug works against cryptococcal meningitis, we can cut mortality rates by 40 to 50 per cent, which would be a huge leap.

Image depicts recent meningitis vaccination programme in Uganda. Copyright Sanjoy Ghosh, courtesy Wikimedia Commons