4 medical devices that could improve trauma care and save lives December 14, 2012 9:11 pm by Stephanie Baum Read more: http://medcitynews.com/2012/12/4-medical-devices-that-could-improve-trauma-care-and-save-lives/#ixzz2FHd0mzaD

The devastating shootings at the Sandy Hook Elementary School in Newtown, Connecticut were a grim reminder that technology developed for combat injuries can be just as critical for non-military situations. Here are four medical devices, some under development for the military and others cleared by the U.S. Food and Drug Administration, that could have a significant impact on saving patients with traumatic injuries.

BleedingZ-Medica initially developed its QuikClot technology to control bleeding for military use but Ron Clark, an emergency medical room physician at the Hospital of Central Connecticut’s Emergency Department, said in an e-mail that the emergency room at the hospital began using the material this year and added that other hospitals have begun using the material.

“I have used it about 10 times for head, extremity, chest and abdominal wound bleeding with very good results,” he said. “It works by using Kaolin to promote clotting and when someone is bleeding out, it works very well.”

Internal bleeding Arsenal Medical is developing a foam that can be injected to control intra-abdominal hemorrhaging. It’s injected at the site of the injury before the injured person is transported to a hospital unit. It compresses the wound internally and conforms to the contours of the internal organs around the injury site. It’s designed to expand the “golden hour” during which trauma patients can be effectively treated by up to three hours and reduce the number of deaths from these wounds. It received a $15.5 million Phase 2 contract from theDefense Advanced Research Projects Agency to develop the medical technology for the mild Brain injury Medical device company InfraScan’s handheld hematoma detector secured 510(k) clearance from the FDA last year. Originally used for combat troops in Afghanistan, the device uses near infrared technology to screen patients for intercranial bleeding in up to two minutes. It acquires EEG data wirelessly and can be used with an Android phone.Hemorrhage control Canadian medical device startup Innovative Trauma Care developed a clamp to control severe bleeding in as little as five seconds. It seals the skin to create a temporary clot to provide stability until the wound can be surgically repaired, according to the company’s website.

Read more: http://medcitynews.com/2012/12/4-medical-devices-that-could-improve-trauma-care-and-save-lives/#ixzz2FHdUi9lA

BOSTON, MA, December 04, 2012 – Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that its ClinPhone® Randomization and Trial...

BOSTON, MA, December 04, 2012 – Perceptive Informatics, a leadingeClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that its ClinPhone® Randomization and Trial Supply Management (RTSM) technologies have been used in over 3,000 studies involving more than 289,000 sites and 1.7 million patients, helping pharmaceutical sponsors to achieve more efficient data collection, faster patient enrollment and more streamlined trial supply management.

“The pressures on the pharmaceutical industry to improve the productivity of the drug development process are greater than ever before, and our goal is to enable clients to successfully meet those challenges by maximizing the value of their clinical trial technologies,” said Nick Richards, Vice President, Product Management, Perceptive Informatics. “Our deep experience is creating significant competitive advantage for us and, going forward, we remain committed to the continuous improvement of our offering based upon this expertise.”

Built on the leading-edge PAREXEL MyTrials™ platform  and combined with PAREXEL’s extensive medical and clinical expertise, ClinPhone RTSM technologies offer validated randomization methods, automated inventory control, dispensing and titration management, emergency code break capabilities and real-time supply reporting. The solutions provide sophisticated reporting to monitor trial management performance, trending and forecasting information, and in-depth data analysis. Clinical trials worldwide can be supported in multiple languages through the solutions, which provide secure access, detailed audit trails, transaction logging and compliance with FDA 21 CFR Part 11.

In addition to the ClinPhone RTSM solution, the comprehensive eClinical portfolio from Perceptive Informatics includes Electonic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Medical Imaging as well as Electronic Patient Reported Outcomes (ePRO). The PerceptiveeClinical Suite provides convergence among systems for real-time data interchange and enables diverse applications to work synergistically.

For more information about the ClinPhone RTSM technologies from Perceptive Informatics, visit www.perceptive.com/ClinPhone-RTSM.

Ground-breaking Liver Cancer Treatment NOVEMBER 26, 2012 BY CLAIRE AL-AUFI

Surgeons in the UK have pioneered a new treatment for cancer that is both unique and promising. The treatment involved isolating a cancerous liver by cutting off its blood supply and at the same time, dousing the organ with a “chemo bath.”

The procedure enables saturation of the tumours with chemotherapy while restricting the effects solely within the infected organ. Brian Stedman, is the consultant radiologist at Southampton General Hospital, who led the team that used the procedure, known as Chemosaturation with Percutaneous Hepatic Perfusion (CS-PHP). There were two patients who underwent the operation because their livers had become cancerous.

A cancerous liver is one where mutated cells grow and take over healthy cells. It is called primary liver cancer if it begins there, but metastatic if it spreads from outside, as with eye melanoma. Around 21, thousand Americans contract primary liver cancer every year. It is unusual in being a cancer on the increase. There are no obvious symptoms, which makes early diagnosis a matter of luck rather than screening. Men are two times more likely to suffer from it than women.

Symptoms to be aware of with advanced stage liver cancer might include tiredness, abdominal bloating, pain high up on the right of abdomen, in your back or shoulder area. Also nausea, loss of appetite, feeling full while losing weight, weakness, fever, and yellowing of the eyes and the skin.

This new CS-PHP treatment was developed in Europe and used successfully in America, Germany, Ireland, Italy and France. A study published in the spring, out of the Moffitt Cancer Center in Tampa, reports that the cancer sufferers that underwent the procedure lived five times longer than patients who underwent traditional treatment.

There are several cancers that invade the liver from original tumors in other organs. Melanoma of the eye is one such. Cancer of the liver is virtually untreatable and four months is the average longevity with only 10% of sufferers living past a year.

CS-PHP significantly adds to the life of melanoma patients while improving the quality of life since the disease progresses no further. The chemotherapy cocktails are infused straight into the liver using a catheter. Blood in the veins, that normally would enter the liver, is diverted and filtered through a purpose made, ‘double-balloon’ catheter to remove all traces of the drug before returning to the organ.

The new methodology enables higher concentrate drugs to be targeted on the liver. It gives maximum impact with minimum ‘collateral damage’. Dr. Stedman comments on the technique,

”To cut off an organ from the body for 60 minutes, soak it in a high dose of drug and then filter the blood almost completely clean before returning is truly groundbreaking.”

He contrasted the new and more traditional treatments where the prognosis for sufferers is dire because of the awful side effects of even low concentrate chemotherapy that wreaks havoc on the whole body. There are possibilities for CS-PHP to be used as a treatment method for other tumors such as in the colon or breast.

Novartis drug helps patients with rare inflammatory diseases

FMF, TRAPS are rare diseases

* Drug reduced attack frequency by 50 pct in FMF patients

* Relieved symptoms in TRAPS patients for average 3 months

ZURICH, Nov 11 (Reuters) - Novartis' Ilaris helps reduce patients' symptoms and the frequency of attacks in two rare inflammatory diseases, mid-stage studies showed, as the Swiss drugmaker looks to expand the use of the medicine.

Results of two separate studies on Sunday in patients with Familial Mediterranean Fever (FMF) and TRAPS - rare genetic diseases which can cause fever, rash and joint pain - both met their primary endpoints, Novartis said in a statement.

Both studies are being presented at the American College of Rheumatology (ACR) meeting in Washington D.C.

Ilaris or ACZ885, which blocks a protein called interleukin-1 beta that is thought to increase inflammation, is already sold for treating cryopyrin-associated periodic syndromes, a rare inflammatory disorder.

Novartis is also hoping to file the drug this year for regulatory approval in systemic juvenile idiopathic arthritis (SJIA), a debilitating disease that can affect a child's growth.

Results of the phase II study showed the drug helped 100 percent of FMF patients reduce the frequency of attacks by at least 50 percent during three months of treatment.

Eight of the nine patients in the trial did not have an attack during the three months and blood markers of inflammation also normalised.

There are currently no approved treatments for FMF or TRAPS, rare genetically-inherited anti-inflammatory diseases, which can affect both children and adults.

Novartis is hoping to show the drug can be beneficial in treating rare inflammatory diseases after receiving a setback last year when U.S. health regulators rejected Ilaris for use in gout over concerns about side effects.

New data from a mid-stage study on the use of Ilaris in TRAPS showed that patients who came off therapy after being treated with the drug did not have a relapse for three months on average.

Earlier data from the study showed that 90 percent of patients experienced a significant improvement in symptoms after just one week of treatment with Ilaris. This rose to 95 percent after two weeks. (Reporting by Caroline Copley; Editing by Elaine Hardcastle)

HEALTHCARE

New Study Uses Animal Model Similar To Humans And Shows BPA Can Affect Thyroid Function Main Category: Endocrinology Also Included In: Pregnancy / Obstetrics; Public Health Article Date: 16 Nov 2012

In utero exposure to bisphenol A (BPA) can be associated with decreased thyroid function in newborn sheep, according to a recent study accepted for publication inEndocrinology, a journal of The Endocrine Society. Hypothyroidism is characterized by poor mental and physical performance in human adults and in children can result in cognitive impairment and failure to grow normally. 

BPA, a major molecule used in the plastic industry, has been shown to be an endocrine disruptor that could exert deleterious effects on human health. Most investigations have focused on reproductive functions, but there is evidence that BPA might have negative effects on other endocrine systems including thyroid function. The current study used sheep, a relevant model for human pregnancy and thyroid regulation and ontogeny, and analyzed the internal exposures of the fetuses and their mothers to BPA and determined to what extent those exposures may be associated with thyroid disruption. 

"Our study is the first to show that BPA can alter thyroid function of pregnant animals and their offspring in a long-gestation species with similar regulation of thyroid function as humans," said Catherine Viguié, PhD, of Toxalim, Research Centre in Food Toxicology in Toulouse, France and lead author of the study. "Because of the potential consequences of maternal/fetal thyroid disruption on neural and cognitive development, we think that our study warrants the need for further investigations on the effect of BPA on thyroid function." 

This study was conducted on adult ewes that had multiple pregnancies before being included in the experiment. Some of the pregnant ewes received daily subcutaneous injections of BPA while the remainder were allocated to the control group. Blood samples were taken from jugular blood, amniotic fluid, placenta samples and cord blood to determine levels of BPA, thyroid-stimulating hormone (TSH) and thyroxine. Results showed that maternal and fetal exposure to BPA was associated with disruption of thyroid function of both the pregnant ewes throughout pregnancy and the newborns as characterized by a decrease in circulating thyroxine levels. 

"BPA concentrations in the mother blood in this experiment were fluctuating between injections from 15 to 1 time the highest blood levels reported in pregnant women in the literature," notes Viguié. "As a consequence, although this study clearly indicates that BPA has the potential to alter thyroid function in living pregnant animals and their offspring, it cannot be considered as fully conclusive in terms of risk for human health in the actual conditions of exposure of human populations." 

"In other words, although our study clearly indicates that BPA-induced thyroid disruption is possible, it does not indicate how probable such a disruption is to occur in real conditions," added Viguié. "Thus, the main merit of our work is to encourage others, including epidemiologists, to scrutinize and qualify carefully such a probability." 

India revokes Roche patent in new blow for Big Pharma By Kaustubh Kulkarni and Ben Hirschler | Reuters – Fri 2 Nov, 2012

MUMBAI/LONDON (Reuters) - India dealt a fresh blow to the international pharmaceutical industry on Friday as its patents appeal board revoked a patent granted six years ago on Roche's hepatitis C drug Pegasys.

The Intellectual Property Appellate Board (IPAB) cited a lack of evidence that the drug was any better than existing treatments and its high price as reasons for the decision.

Pegasys was the first medicine to win protection in 2006 under India's new patent regime and the revocation will rekindle tensions between New Delhi and global drugmakers worried by the country's tough stance.

The decision follows another high-profile setback for the industry in March, when India granted the first ever compulsory licence to domestic drugmaker Natco to sell cheap copies of Bayer's cancer drug Nexavar.

Multinational drug manufacturers see India's $12 billion drug market as a huge opportunity, but are wary of what they see as lax protection for intellectual property in a country where generic medicines account for more than 90 percent of sales.

Indian generic companies, which do not need to plough money back into future research, can produce drugs at a fraction of the cost of originator firms like Roche or Bayer.

Sankalp Rehabilitation Trust, an advocacy group for cheaper medicines, had challenged the Pegasys patent with the IPAB, saying the drug was costly and gave the Swiss company a monopoly in the market for the drug.

The market price of Pegasys is 436,000 rupees for 48 weeks of treatment, although it is also available at a discounted price of 314,496 rupees, Sankalp said in a statement.

Pegasys is given in combination with another drug, ribavirin, which costs 47,160 rupees for the same period, Sankalp added.

The appeals board on Friday termed Sankalp's plea "valid."

PAYING FOR INNOVATION

Roche, which can appeal the decision to the Supreme Court, said it was reviewing the IPAB decision and could not comment on it in detail. But it said a solid system of patent protection was essential to ensure research into new treatments.

"Many of the generic drugs today used in India were once patent-protected and are only available to society because companies such as Roche were willing to take a risk by investing in new innovative drugs," a company spokesman said.

He added that Roche was assessing a number of different ways to make drugs accessible to patients in poorer countries, including volume discounts, rebates and price capping.

Campaigners for greater healthcare access contend that the best way to ensure low drug prices is to maximise generic competition by challenging unjustified patents.

Leena Menghaney, a manager in New Delhi for Medecins Sans Frontieres (MSF), said this was particularly important in a disease area like hepatitis C, which is a growing problem in many Asian countries and often hits the most vulnerable in society.

"This case shows that if people choose to use different public health safeguards in Indian law to check abuse of the patent system, then indeed they do work," she said.

Another case involving drug patents is currently in front of India's the Supreme Court, with Novartisbattling against an earlier decision refusing it a patent on cancer drug Glivec.

India is also taking a tougher line on drug pricing more generally, with plans to increase dramatically the number of essential drugs subject to price regulation.

(Reporting by Kaustubh Kulkarni; Editing by Tony Munroe and David Cowell)

Cognitive behavioural therapy (CBT) for anxiety in people with dementia: study protocol for a randomised controlled trial

Background

Many people with dementia experience anxiety, which can lead to decreased independence, relationship difficulties and increased admittance to care homes. Anxiety is often treated with antipsychotic medication, which has limited efficacy and serious side effects. Cognitive behavioural therapy (CBT) is widely used to treat anxiety in a range of populations, yet no RCTs on CBT for anxiety in dementia exist. This study aims to develop a CBT for anxiety in dementia manual and to determine its feasibility in a pilot RCT.

Methods

Phase I involves the development of a CBT for anxiety in dementia manual, through a process of (1) focus groups, (2) comprehensive literature reviews, (3) expert consultation, (4) a consensus conference and (5) field testing. Phase II involves the evaluation of the manual with 50 participants with mild to moderate dementia and anxiety (and their carers) in a pilot, two-armed RCT. Participants will receive either ten sessions of CBT or treatment as usual. Primary outcome measures are anxiety and costs. Secondary outcome measures are participant quality of life, behavioural disturbance, cognition, depression, mood and perceived relationship with the carer, and carer mood and perceived relationship with the person with dementia. Measures will be administered at baseline, 15 weeks and 6 months. Approximately 12 qualitative interviews will be used to gather service-users' perspectives on the intervention.

Discussion

This study aims to determine the feasibility of CBT for people with anxiety and dementia and provide data on the effect size of the intervention in order to conduct a power analysis for a definitive RCT. The manual will be revised according to qualitative and quantitative findings. Its publication will enable its availability throughout the NHS and beyond.