My Clinical Trials Diary

May the holidays be filled with fun, laughter, health and happiness! Love and Peace! Vidya Sury  

Shri Arun Madhavan's talk at Purna Pragnya. He speaks of what the children of Purna Pragnya must feel when they leave after finishing their studies. He gives a glimpse of the fundamentally simple meaning of our life.

News item: Source BioSpectrum, Asia Edition Singapore, Nov 4, 2010: Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has announced that its dengue vaccine is in final stage of clinical development. Sanofi Pasteur’s dengue vaccine, the world’s most clinically advanced dengue vaccine candidate entered its first phase III clinical study in Australia.  This study is part of a global phase III clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur.  Phase III studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur’s candidate dengue ...

After tests revealed too-rapid release of active ingredient about one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. Approximately one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. The U.S. Food and Drug Administration and drug maker Actavis Inc. are working to get the word out, but they are targeting retailers and wholesalers, not consumers. Continue reading

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used. By Daniel J. DeNoon WebMD Health News Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug. The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval. The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control. New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos . Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia. "Avandia will be ava...

Once-Daily Capsules Cut MS Relapses, Delay Progression   By Daniel J. DeNoon WebMD Health News   Sept. 22, 2010 -- The FDA today approved Novartis' Gilenya, the first oral drug for multiple sclerosis (MS). Gilenya (formerly spelled Gilenia, generic name fingolimod) last June received the overwhelming approval of an FDA expert advisory panel. Gilenya treats the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised. In MS, white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph node door. Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections. Novartis will set ...

“Anxious mothers are feeding children excessive dosages” “Overdose can happen more easily in children” ‘Drops' version mistaken for syrup Even love is valuable only if it is given in the right dosage. Overdoses of drugs, specially the common paracetamol, need not be dangerous in adults, but can lead to serious complications, including liver failure, in children. Over the past few weeks, with viral and flu infections rampant, a number of children have been admitted to the intensive care units, not for treatment of the primary illness, but for paracetamol poisoning. Janani Sankar, senior consultant, Kanchi Kamakoti CHILDS Trust Hospital, says kids come in with multi-organ failure, and while most of them could be saved, some have been beyond help as they have come too late. “Two types of overdosing can occur: one is accidental, when the children drink up syrup because it is tasty; or two doses are taken by mistake. The other is what we are commonly seeing now: mothers with...

As Member Secretary of CLINICOM, I am so thrilled to post this information here: ''Dynamic Indian of the millenium" award conferred   Coimbatore, Jul 4 (PTI) City-based K G Foundation today conferred the 'Dynamic Indian of the Millennium' award on Arun Madhavan , a former member of Prime Minister's special committee for model village development programme under the 20-point programme. The award, carrying a citation, was given for his 'distinguished achievements and contribution to society over the years', the foundation chairman G Bhakthavatsalam, said at a function got up as part of the celebrations of World Doctors' Day, here. Besides being conferred a global recognition for his 'project gateway' for promoting India as an investment destination, Arun had delivered a speech at the United Nationas, Geneva, on 'A New dimension to healthcare,' in 1996, he said. The first recipient of this award was the former president, A P ...

A new website will help people decide which therapies are safe and effective. By Sandy Kleffman, Contra Costa Times Leading scientists are warning people to beware of costly, unproven stem cell therapies that have little or no benefit and may be dangerous. Many with devastating illnesses are mortgaging their homes and borrowing huge sums of money for treatments, which are often performed outside the United States to avoid its safety regulations. Scientists worry that such therapies could harm people by leading to cancers and other complications. "It's really the 21st century version of snake oil," said Dr. Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UC San Francisco. "As soon as you scratch the surface, you realize that what they're claiming in their literature or what they tell you about, doesn't make sense," he said. "There's this notion that stem cells are in so...

  Two new studies suggest there's a connection between parents who smoke and kids who are heavier or misbehave more than other children. The researchers haven't definitively proven that lighting up puts kids at risk for bad behaviour and extra pounds. In fact, it may be impossible to ever prove a cause-and-effect because it's considered unethical to assign some parents to smoke and then see what happens. Still, the findings "tighten the link" between parents who smoke and physical and mental health problems in their kids, said Dr Jonathan Winickoff, an associate professor of pediatrics at Massachusetts General Hospital, who co-wrote a commentary accompanying the research. For decades, doctors have advised pregnant women to avoid smoking for fear that they would harm their unborn children; research has linked smoking in mothers to physical problems in offspring such as low birth weight. If the mother smokes during the first trimester, the effect...

NEW YORK (Reuters Health) - Two reports today in two separate journals -- a meta-analysis and a large retrospective study -- provide more evidence linking the thiazolidinedione rosiglitazone to an increased risk of myocardial infarction (MI). The retrospective study also ties rosiglitazone therapy to an increased risk of stroke, heart failure, and death from any cause in patients aged 65 and older. In an e-mail to Reuters Health, Dr. Steven E. Nissen, chair of the Department of Cardiovascular Medicine at The Cleveland Clinic and a long-time vocal critic of rosiglitazone, said the two manuscripts "provide overwhelming evidence of the hazards" of the drug. "Taken together," he wrote, "the two studies demonstrate that this drug has an adverse benefit risk relationship and should be removed from the market. I would advise physicians who are still using rosiglitazone to stop and begin switching their patients to safer alternatives, including pioglit...