India to inspect drug firms in China: DCGI Inspection Office To Open In Beijing By Mar 1 Kounteya Sinha TNN

New Delhi: Increasing the heat on Chinese drug firms exporting medicines to India, the Drug Controller General of India (DCGI) is all set to open its first foreign drug inspection office in Beijing by March 1. 
    Around four Indian drug inspectors will be posted in China to inspect manufacturing sites and check whether good manufacturing practices (GMP) are being complied with. DCGI Dr G N Singh told TOI that the commerce ministry has cleared the proposal. 
    Health minister Ghulam Nabi Azad recently said that in the last two years, 10 Chinese bulk drug manufacturing firms were inspected and the registration certificate of one firm and 16 import licences were cancelled. 
    Ministry sources said the decision to audit Chinese drug manufacturing units was taken after several import licences of local agents were cancelled due to poor drug quality and their failure to comply with GMP. 
    “We will post Indian drug inspectors in China to send a clear message that Chinese drug firms are under watch. Gradually, China will be asked to only allow drugs exports from manufacturing sites that have been inspected by Indian drug inspectors. We want to ensure safety, efficacy and quality of Chinese drugs,” said Dr Singh. 
    “GMP of Chinese drug firms has to be certified by our regulators. This is a practice followed in most countries, including the FDA in the US. To protect the interest of Indians, we have to go international,” he added. 
    Now, more than 45% of bulk drug exporters registered in India are from China. The number of registered Chinese bulk drug manufacturers in India is around 280, and altogether 417 different drugs from the Asian giant are registered. 
    A ministry official said, “We had earlier written to Chinese Food and Drug Authority (FDA) regarding complaints that some Chinese drug firms which export bulk drugs to India might not be holding proper GMP certificates. The Chinese FDA too confirmed our apprehensions and asked us to carry out our own inspections.” On the basis of complaints and doubts on authenticity of GMP certificate, India has already cancelled 10 registration certificates and related import licences. These certificates were from Zhejinag, Jingsu, Henan province and Chongquing. 
    A DCGI note said, “Similarly, several cases of imported kits of HIV were declared to be not of standard quality by the government laboratory, which are originating from Zhejiang and Fujian provinces. These issues further support this office which stands to carry out foreign site inspections in line with other regulatory agencies of the world.”

More than 45% of bulk drug exporters registered in India are from China

Coffee Drinking May Halve Risk Of Mouth And Throat Cancer Featured Article Academic Journal Main Category: Cancer / Oncology Also Included In: Nutrition / Diet; Dentistry Article Date: 12 Dec 2012 - 3:00 PST

A new study from the US finds people who drink more than 4 cups of caffeinated coffee a day have half the risk of dying from oral/pharyngeal (mouth and throat) cancer as people who drink it either occasionally or not at all. However, the researchers say their findings need to be confirmed by more research, and for now should just be received as good news for coffee drinkers and not be used as a reason to recommend everyone should drink 4 cups of coffee a day.

Lead author Janet Hildebrand and colleagues from the American Cancer Society (ACS) in Atlanta, Georgia, write about their findings in a paper published online first on 9 December in the American Journal of Epidemiology.

Oral/Pharyngeal Cancer

Oral/pharyngeal or mouth and throat cancer is rarely diagnosed in the early stages because symptoms usually do not appear until the cancer is advanced. Also, the symptoms can be mistaken for something else, such as toothache.

The cancer can sometimes be spotted early during a routine exam by a doctor, dentist, or dental hygienist, and some dentists and doctors suggest you look at your mouth in a mirror at least once a month to check for symptoms.

The most common symptoms are a mouth sore that fails to heal, or a pain in the mouth that doesn't go away.

The biggest risks for developing oral/pharyngeal cancer are tobacco and alcohol use. Most people who have it are tobacco users.

Infection with the human papillomavirus (HPV) is also a risk factor, especially in people who do not use tobacco. The number of cases of oral/pharyngeal cancer tied to HPV has risen sharply in the last thirty years.

Researchers Examine Link with Coffee

Previous epidemiological studies have suggested coffee drinking is linked to a reduced risk for mouth and throat cancer.

It has also been suggested that it may not be the caffeine in coffee, but the fact it is rich in antioxidants, polyphenols, and other compounds, that help prevent or slow the development of cancer.

For their study, Hildebrand and colleagues used data from the Cancer Prevention Study II, a prospective US cohort study that the ACS started in 1982.

That study gathered a wealth of lifestyle and health information on 968,432 men and women, including their tea and coffee consumption. When they enrolled on the study, none of the participants had cancer, but over the 26 years of follow up, 868 died from oral/pharyngeal cancer.

When they analyzed the tea and coffee consumption in relation to deaths from oral/pharyngeal cancer, the researchers found those participants who reported drinking more than 4 cups of caffeinated coffee a day had a 49% lower risk of death from oral/pharyngeal cancer compared to those who reported not drinking coffee at all or only an occasional cup.

The link was not affected by gender, tobacco and alcohol use.

The researchers found an insignificant link with decaffeinated coffee, and none at all with tea.

Conclusion and Next Step

The researchers conclude:

"In this large prospective study, caffeinated coffee intake was inversely associated with oral/pharyngeal cancer mortality. Research is needed to elucidate biologic mechanisms whereby coffee might help to protect against these often fatal cancers."

Hildebrand says in a press statement:

"We are not recommending people all drink 4 cups of coffee a day. This is just a little bit of good news for those of us who enjoy coffee."

"There may be some other effects of coffee that may prevent people with certain conditions from drinking a lot of caffeine," she cautions, noting that:

"This study is about just one cancer site among many. There needs to be much more consistent research before we can support the conclusion that coffee should be consumed for cancer prevention."

The team is now planning to analyze links between coffee consumption and cancer in a more diverse population in the ACS's new Cancer Prevention Study - 3 (CPS-3).

The Society hopes to recruit at least 300,000 adults from a range of ethnic and racial backgrounds across the US to take part in CPS-3, which aims to increase knowledge of how to prevent cancer.

There has been a lot of debate recently about the benefits and harms of coffee drinking, with more recent news suggesting the benefits probably outweigh the harms.

But researchers spreading the good news are all saying the same thing, as Hildebrand and colleagues themselves point out in this latest study: while there appear to be some health perks from drinking coffee, there are also a few cautions, and the evidence is not solid enough to actively encourage people to go out and drink coffee.

Written by Catharine Paddock PhD 
Copyright: Medical News Today 
Not to be reproduced without permission of Medical News Today 

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."